{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 63 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "9612197-2020-00010", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200729", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200622", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "UK", "manufacturer_contact_area_code": "", "date_added": "20200729", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "806017", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20200729", "brand_name": "AURICAL AUD/PMM, 1081", "generic_name": "AURICAL AUD/PMM, 1081", "manufacturer_d_name": "NATUS MEDICAL DENMARK", "manufacturer_d_address_1": "HOERSKAETTEN 9", "manufacturer_d_address_2": "", "manufacturer_d_city": "TAASTRUP 2630,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "DA", "manufacturer_d_postal_code": "", "device_operator": "I", "model_number": "8-04-14500", "catalog_number": "8-04-14500", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200831", "device_report_product_code": "EWO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "9612197" ], "fei_number": [ "3002807554" ], "device_name": "Audiometer", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.1050", "device_class": "2" } } ], "product_problems": [ "Melted", "Battery Problem", "Battery Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/27/2020;07/27/2020;07/27/2020;07/27/2020;07/27/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200729", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Not Applicable", "No Clinical Signs, Symptoms or Conditions", "Not Applicable", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10339183", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200727", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320613047", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AURICAL FREEFIT - RECHARGEABLE BATTERY HAS MELTED." }, { "mdr_text_key": "320613048", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATE 22 OCT 2020 (FOLLOW UP 003). CAPA004611 HAS BEEN GENERATED TO INVESTIGATE THIS ISSUE. CONCLUSION ON ROOT CAUSE IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. THE PLAN FOR CORRECTIVE ACTIONS IS CURRENTLY ONGOING UNDER CAPA004611 AND ARE AS FOLLOWS: CA 1: USER GUIDE UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE OCT 1, 2020). CA 2: SERVICE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 3: REFERENCE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 4: CHANGE BATTERY WHERE USED IN 1053 BOMS. (DUE DEC 1, 2020). CA 5: SERVICE SPEC. UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (JUL 1, 2020). OVER ALL STATUS OF CAPA IS ON TRACK: CA1: -PROTO VERSION OF IFU RELEASED. CA2: -PROTO VERSION OF IFU RELEASED. CA3: -PROTO VERSION OF IFU RELEASED. CA4: NEW BATTERY IDENTIFIED. ECR#(B)(4) IS RELEASED. DCP (B)(4) RELEASED. BOM CHANGES PREPARED WITH ECO#34922. TECH. DESIGN REVIEW (B)(4) RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION IS STARTED. ESTIMATED COMPLETION IS WEEK 02 NOV 2020. CA5: COMPLETED WITH THIS RATIONALE: \"TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2\". CA6: QMS-005706 IS RELEASED. ELEAP TRAINING IS PREPARED AND READY FOR SUBMISSION. OTHER ACTIONS TAKEN: WEEKLY FOLLOW-UP MEETINGS SCHEDULED. REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED." }, { "mdr_text_key": "320614436", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AURICAL FREEFIT - RECHARGEABLE BATTERY HAS MELTED." }, { "mdr_text_key": "320614437", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATE 14 DEC 2020 (FOLLOW UP 004) REF # (B)(4). CAPA004611 HAS BEEN GENERATED TO INVESTIGATE THIS ISSUE. CONCLUSION ON ROOT CAUSE IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. THE PLAN FOR CORRECTIVE ACTIONS IS CURRENTLY ONGOING UNDER CAPA004611 AND ARE AS FOLLOWS: CA 1: USER GUIDE UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE OCT 1, 2020). CA 2: SERVICE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 3: REFERENCE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 4: CHANGE BATTERY WHERE USED IN 1053 BOMS. (DUE DEC 1, 2020). CA 5: SERVICE SPEC. UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (JUL 1, 2020). OVER ALL STATUS OF CAPA IS ON TRACK: CA1: -PROTO VERSION OF IFU RELEASED. CA2: -PROTO VERSION OF IFU RELEASED. CA3: -PROTO VERSION OF IFU RELEASED. CA4: NEW BATTERY IDENTIFIED. (B)(4) IS RELEASED. DCP (B)(4) RELEASED. TECH. DESIGN REVIEW (B)(4) RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION REPORT IS RELEASED WITH (B)(4) . BATTERY IS RELEASED WITH (B)(4). BOM CHANGES PREPARED WITH (B)(4). CA5: COMPLETED WITH THIS RATIONALE: \"TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2\". CA6: QMS-005706 IS RELEASED. ELEAP TRAINING IS SET UP. OTHER ACTIONS TAKEN: REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611." }, { "mdr_text_key": "320146251", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATE 27 AUGUST 2020 (FOLLOW UP 001). CAPA004611 HAS ALREADY BEEN GENERATED TO INVESTIGATE THIS ISSUE. CONCLUSION ON ROOT CAUSE IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. THE PLAN FOR CORRECTIVE ACTIONS IS CURRENTLY ONGOING UNDER CAPA004611 AND ARE AS FOLLOWS: CA 1: USER GUIDE UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE OCT 1, 2020). CA 2: SERVICE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 3: REFERENCE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 4: CHANGE BATTERY WHERE USED IN 1053 BOMS. (DUE DEC 1, 2020). CA 5: SERVICE SPEC. UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (JUL 1, 2020). OVERALL STATUS: ON TRACK. CA1: DRAFT PREPARED AND REVIEWED. CA2: DRAFT PREPARED AND REVIEWED. CA3: DRAFT PREPARED AND REVIEWED. CA4: NEW BATTERY IDENTIFIED. SUSTAINING DESIGN CHANGE INITIATED. CA5: COMPLETED WITH THIS RATIONALE: \"TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2\". CA6: QMS-005706 DOCUMENT IS RELEASED. TRAINING IS PREPARED AND READY FOR SUBMISSION. OTHER ACTIONS TAKEN: REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED TO UPDATE THE RISK ASSESSMENT. EFFECTIVITY CHECK PLAN TO BE CARRIED OUT ON THIS CAPA BEFORE CLOSURE." }, { "mdr_text_key": "320146252", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AURICAL FREEFIT - RECHARGEABLE BATTERY HAS MELTED." }, { "mdr_text_key": "205010594", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. AWAITING RETURN OF THE DEVICE FROM THE CUSTOMER. A COMPLETE EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE." }, { "mdr_text_key": "205010595", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AURICAL FREEFIT: RECHARGEABLE BATTERY HAS MELTED." }, { "mdr_text_key": "315214365", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AURICAL FREEFIT - RECHARGEABLE BATTERY HAS MELTED." }, { "mdr_text_key": "315214386", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATE 25 SEPT 2020 (FOLLOW UP 002) REF NATUS COMPLAINT# (B)(4). CAPA004611 HAS BEEN GENERATED TO INVESTIGATE THIS ISSUE. CONCLUSION ON ROOT CAUSE IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. THE PLAN FOR CORRECTIVE ACTIONS IS CURRENTLY ONGOING UNDER CAPA004611 AND ARE AS FOLLOWS: CA 1: USER GUIDE UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE OCT 1, 2020). CA 2: SERVICE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 3: REFERENCE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG 1, 2020). CA 4: CHANGE BATTERY WHERE USED IN 1053 BOMS. (DUE DEC 1, 2020). CA 5: SERVICE SPEC. UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (JUL 1, 2020). OVERALL STATUS OF CAPA IS ON TRACK: CA1: -PROTO VERSION OF IFU SUBMITTED WITH ECO# (B)(4). CA2: -PROTO VERSION OF IFU SUBMITTED WITH ECO# (B)(4). CA3: -PROTO VERSION OF IFU SUBMITTED WITH ECO# (B)(4). CA4: NEW BATTERY IDENTIFIED. ECR#18858 IS RELEASED. CA5: COMPLETED WITH THIS RATIONALE: \"TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2\". CA6: QMS-005706 RELEASED WITH DCO#40712. ELEAP TRAINING IS PREPARED AND READY FOR SUBMISSION. OTHER ACTIONS TAKEN: WEEKLY FOLLOW-UP MEETINGS SCHEDULED. REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED." }, { "mdr_text_key": "321817893", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 05 JAN 2021 ((FOLLOW UP 005) REF NATUS COMPLAINT#: (B)(4). CONCLUSION ON ROOT CAUSE OF THIS EVENT IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. CAPA004611 WAS GENERATED TO INVESTIGATE THIS ISSUE. CORRECTIVE ACTION PLAN FOR CAPA004611. CA 1: USER GUIDE (7-50-1220-XX) UPDATED - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATED. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATED. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 4: CHANGED BATTERY (8-73-02200 WHERE USED IN 1053 BILL OF MATERIALS). CA 5: SERVICE SPECIFICATION. (0-80-00311) UPDATED. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE. CA 6: CREATED NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE. FINAL STATUS OF CAPA004611: CA1: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA2: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA3: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA4: COMPLETED AS FOLLOWS: NEW BATTERY IDENTIFIED AND RELEASED. DOC-048835 - 1053 FREEFIT BATTERY CHANGE - DESIGN PLANNING CHECKLIST RELEASED. DOC-048834 - 1053 FREEFIT BATTERY CHANGE - TECHNICAL DESIGN REVIEW RECORD RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION REPORT IS RELEASED. RII FOR BATTERY IS RELEASED . BOM CHANGES ARE RELEASED. DMR UPDATES ARE RELEASED. CA5: COMPLETED WITH THIS RATIONALE: \"TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2\". CA6: QMS-005706 - FS - SERVICE NOTE 20-01 ANNUAL 1053 AURICAL PMM BATTERY REPLACEMENT WORK INSTRUCTION RELEASED. (INCLUDING ELEAP TRAINING SET UP). EFFECTIVITY CHECK PLAN WILL BE CARRIED OUT ON CAPA006611 AS FOLLOWS: CONTINUE COMPLAINT TRENDING ON QUARTERLY BASIS ON THE ISSUE (MELTING PLASTIC IN BATTERY COMPARTMENT) FOR ONE YEAR FROM IMPLEMENTATION OF ACTIONS. NEW BATTERY IS PART NO. 031814 (PANASONIC: BK200AAB). ACCEPTANCE CRITERIA: < 1 COMPLAINT INVOLVING THE NEW BATTERY. FAIL CRITERIA: > 0 COMPLAINT INVOLVING THE NEW BATTERY. RISK WAS ASSESSED AS MINOR (3) AND PRODUCT RISK IS CONSIDERED TOLERABLE, AS PER QMS-001647 RISK MANAGEMENT INSTRUCTION FOR THE POTENTIAL HAZARD OF MINOR USER BURN, AND DELAYED PATIENT DIAGNOSIS IF EQUIPMENT BECOMES NON-FUNCTIONAL. THE BENEFIT OF THE DEVICE OUTWEIGHS THE MINOR RISK REMAINING." }, { "mdr_text_key": "321817894", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AURICAL FREEFIT - RECHARGEABLE BATTERY HAS MELTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/27/2020;09/25/2020;10/22/2020;12/14/2020;01/05/2021" } ] }