{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 307757 } }, "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": "Injury", "report_number": "2951250-2020-05673", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P020014", "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": [ "CONSUMER", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466244", "implant_date_year": "2009", "date_removed_year": "2021", "serviced_by_3rd_party_flag": "U", "date_received": "20200427", "brand_name": "ESSURE", "generic_name": "TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE", "manufacturer_d_name": "BAYER PHARMA AG", "manufacturer_d_address_1": "MÜLLERSTR. 178", "manufacturer_d_address_2": "", "manufacturer_d_city": "BERLIN,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "13353", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "GM", "manufacturer_d_postal_code": "13353", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ESS305", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HHS", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10888853003051", "udi_public": "(01)10888853003051", "openfda": { "device_name": "Transcervical Contraceptive Tubal Occlusion Device", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.5380", "device_class": "3" } } ], "product_problems": [ "Biocompatibility", "Adverse Event Without Identified Device or Use Problem", "Patient Device Interaction Problem", "Biocompatibility", "Adverse Event Without Identified Device or Use Problem", "Patient Device Interaction Problem" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/22/2020;07/15/2021", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "37 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pain", "Genital Bleeding", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Genital Bleeding" ] } ], "distributor_city": "", "date_report": "20210720", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000131", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20151012", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320121411", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5044397) ON 12-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 22-JUN-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND URINARY TRACT INFECTION ('I KEEP UTI/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LABOR PAIN ON (B)(6) 2009 AND MULTIGRAVIDA. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN (\"BACK PAIN/LOWER BACK PAIN\"), DYSPAREUNIA (\"PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)\"), MENORRHAGIA (\"HEAVY MENSTRUAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)\"), VAGINAL HAEMORRHAGE (\"ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)\"), MIGRAINE (\"MIGRAINES / HEADACHES\") AND ALLERGY TO METALS (\"NICKEL ALLERGY\"). ON (B)(6) 2020, THE PATIENT EXPERIENCED TOOTH DISORDER (\"DENTAL PROBLEMS\"), 10 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE (\"HEADACHES\"), DYSGEUSIA (\"TASTE IN MOUTH THAT WONT GO AWAY/METAL TASTE IN HER MOUTH\"), PELVIC PAIN (\"PELVIC PAIN/SEVERE PAIN ALL THE TIME\") AND ABDOMINAL PAIN LOWER (\"CRAMPING\"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, HEADACHE, DYSGEUSIA, PELVIC PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA AND MENORRHAGIA HAD NOT RESOLVED AND THE URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, MIGRAINE, ALLERGY TO METALS AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSGEUSIA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AN INTERVENTION WAS MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. SHE STATED HER DOCTOR TOLD THAT SHE WOULD HAVE TO HAVE A HYSTERECTOMY TO HAVE IT (ESSURE) REMOVED. SHE ALSO SAID THAT IS THE ONLY WAY TO REMOVE IT. SHE DID NOT HAVE A HYSTERECTOMY YET. SHE WENT TO HER DOCTOR YESTERDAY ON (B)(6) 2015 AND SHE WANTS ME TO COME BACK ON THE (B)(6) 2015 TO DISCUSS SCHEDULING THE HYSTERECTOMY. THE CONSUMER STATED SHE DOES NOT WANT TO HAVE A HYSTERECTOMY AS SHE WAS 33 YEARS OLD; AND SHE WANTED A SECOND OPINION. PREVIOUSLY REPORTED INSERTION DATE WAS (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: THE COILS WERE IN THE PROPER PLACE; ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION, EVERYTHING LOOKED GOOD: IT WAS SUCCESSFUL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. ON 8-JUN-2020: FU10&11 PROCESS TOGETHER- PIF RECEIVED: NO NEW INFORMATION WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." }, { "mdr_text_key": "325695808", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5044397) ON 12-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 15-JUL-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/SEVERE PAIN ALL THE TIME'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND URINARY TRACT INFECTION ('I KEEP UTI/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LABOR PAIN ON (B)(6) 2009 AND MULTIGRAVIDA. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN (\"BACK PAIN/LOWER BACK PAIN\"), DYSPAREUNIA (\"PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)\"), HEAVY MENSTRUAL BLEEDING (\"HEAVY MENSTRUAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)\"), VAGINAL HAEMORRHAGE (\"ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)\"), MIGRAINE (\"MIGRAINES / HEADACHES\") AND ALLERGY TO METALS (\"NICKEL ALLERGY\"). ON (B)(6) 2020, THE PATIENT EXPERIENCED TOOTH DISORDER (\"DENTAL PROBLEMS\"), 10 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE (\"HEADACHES\"), DYSGEUSIA (\"TASTE IN MOUTH THAT WONT GO AWAY/METAL TASTE IN HER MOUTH\") AND ABDOMINAL PAIN LOWER (\"CRAMPING\"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC TLH BILATERAL SALPINGECTOMY AND ANTERIOR POSTERIOR REPAIR WITH ENTEROCELE REPAIR). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HEADACHE, DYSGEUSIA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA AND HEAVY MENSTRUAL BLEEDING HAD NOT RESOLVED AND THE URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, MIGRAINE, ALLERGY TO METALS AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSGEUSIA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AN INTERVENTION WAS MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. SHE STATED HER DOCTOR TOLD THAT SHE WOULD HAVE TO HAVE A HYSTERECTOMY TO HAVE IT (ESSURE) REMOVED. SHE ALSO SAID THAT IS THE ONLY WAY TO REMOVE IT. SHE DID NOT HAVE A HYSTERECTOMY YET. SHE WENT TO HER DOCTOR YESTERDAY ON (B)(6) 2015 AND SHE WANTS ME TO COME BACK ON THE (B)(6) 2015 TO DISCUSS SCHEDULING THE HYSTERECTOMY. THE CONSUMER STATED SHE DOES NOT WANT TO HAVE A HYSTERECTOMY AS SHE WAS 33 YEARS OLD; AND SHE WANTED A SECOND OPINION. PREVIOUSLY REPORTED INSERTION DATE WAS (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: THE COILS WERE IN THE PROPER PLACE; ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION, EVERYTHING LOOKED GOOD: IT WAS SUCCESSFUL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-JUL-2021: MR RECEIVED. ESSURE REMOVAL DATE, SURGERY WAS ADDED TO EVENT PELVIC PAIN. REPORTER INFORMATION ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." }, { "mdr_text_key": "196864867", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5044397) ON 12-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND URINARY TRACT INFECTION ('I KEEP UTI/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LABOR PAIN ON (B)(6) 2009 AND MULTIGRAVIDA. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN (\"BACK PAIN/LOWER BACK PAIN\"), DYSPAREUNIA (\"PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)\"), MENORRHAGIA (\"HEAVY MENSTRUAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)\"), VAGINAL HAEMORRHAGE (\"ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)\"), MIGRAINE (\"MIGRAINES / HEADACHES\") AND ALLERGY TO METALS (\"NICKEL ALLERGY\"). ON (B)(6) 2020, THE PATIENT EXPERIENCED TOOTH DISORDER (\"DENTAL PROBLEMS\"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE (\"HEADACHES\"), DYSGEUSIA (\"TASTE IN MOUTH THAT WONT GO AWAY/METAL TASTE IN HER MOUTH\"), PELVIC PAIN (\"PELVIC PAIN/SEVERE PAIN ALL THE TIME\") AND ABDOMINAL PAIN LOWER (\"CRAMPING\"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, HEADACHE, DYSGEUSIA, PELVIC PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA AND MENORRHAGIA HAD NOT RESOLVED AND THE URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, MIGRAINE, ALLERGY TO METALS AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSGEUSIA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AN INTERVENTION WAS MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. SHE STATED HER DOCTOR TOLD THAT SHE WOULD HAVE TO HAVE A HYSTERECTOMY TO HAVE IT (ESSURE) REMOVED. SHE ALSO SAID THAT IS THE ONLY WAY TO REMOVE IT. SHE DID NOT HAVE A HYSTERECTOMY YET. SHE WENT TO HER DOCTOR YESTERDAY ON (B)(6) 2015 AND SHE WANTS ME TO COME BACK ON THE (B)(6) 2015 TO DISCUSS SCHEDULING THE HYSTERECTOMY. THE CONSUMER STATED SHE DOES NOT WANT TO HAVE A HYSTERECTOMY AS SHE WAS (B)(6) YEARS OLD; AND SHE WANTED A SECOND OPINION. PREVIOUSLY REPORTED INSERTION DATE WAS (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: THE COILS WERE IN THE PROPER PLACE; ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION, EVERYTHING LOOKED GOOD: IT WAS SUCCESSFUL. QUALITY-SAFETY EVALUATION OF PTC: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2020: INFORMATION RECEIVED VIA PLAINTIFF FACT SHEET. NEW EVENT: DENTAL PROBLEMS. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." } ], "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": "07/01/2020;07/20/2021" } ] }