{ "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": 26072 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "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": "Death", "report_number": "3006646024-2020-00013", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K924065", "date_of_event": "20200228", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER", "USE" ], "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": "463335", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR", "generic_name": "DH EF PEG INITIAL PLACEMENT PRODUCTS", "manufacturer_d_name": "AVANOS MEDICAL INC.", "manufacturer_d_address_1": "5405 WINDWARD PARKWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "ALPHARETTA", "manufacturer_d_state": "GA", "manufacturer_d_zip_code": "30004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "30004", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210531", "model_number": "8160-20", "catalog_number": "N/A", "lot_number": "20016182", "other_id_number": "", "device_availability": "No", "device_report_product_code": "KNT", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Tubes, Gastrointestinal (And Accessories)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5980", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "ME", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/29/2020;06/05/2020", "mfr_report_type": "", "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": [ "Death" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Sudden Cardiac Death", "No Code Available", "Cardiac Arrest", "Sudden Cardiac Death", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200624", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000881", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200410", "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": "189008724", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). ALL INFORMATION REASONABLY KNOWN AS OF 24 APR 2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4)." }, { "mdr_text_key": "189008725", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS PLACED, THE PATIENT BEGAN EXPERIENCING ABDOMINAL DISCOMFORT. A CT SCAN WITHOUT CONTRAST WAS PERFORMED, WHICH SHOWED FREE AIR IN THE ABDOMEN, WHICH WAS THOUGHT TO BE RELATED TO THE PEG TUBE PLACEMENT. PATIENT WAS GIVEN OXYGEN VIA BAG MASK, ATROPINE 0.5 MG IV X 2 DOSES, AND A DOPAMINE DRIP. AFTER TREATMENT, NO PULSE WAS DETECTED AND PATIENT WAS PRONOUNCED DECEASED. PER ADDITIONAL INFORMATION RECEIVED ON 15 APR 2020, THE CAUSE OF DEATH WAS CARDIAC ARREST, AND IT IS UNKNOWN IF THE INCIDENT WAS RELATED TO THE PEG TUBE. THE PEG TUBE HAD BEEN PLACED ON (B)(6) 2020." }, { "mdr_text_key": "316110605", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2020, THE INITIAL DIAGNOSIS WAS BACTERIAL PNEUMONIA AND DYSARTHRIA. AFTER THE REPORTED INCIDENT THE TUBE WAS LEFT IN PLACE IN THE PATIENT. THE PATIENT'S CAUSE OF DEATH IS REPORTED ON THE DEATH CERTIFICATE AS CARDIAC ARREST." }, { "mdr_text_key": "316110626", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY." }, { "mdr_text_key": "316201852", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PER ADDITIONAL INFORMATION RECEIVED 29 APR 2020, THE FREE AIR IN THE ABDOMEN WAS IN THE PERITONEUM. THERE WAS NO ORGAN PERFORATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED." }, { "mdr_text_key": "316201853", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ALL INFORMATION REASONABLY KNOWN AS OF 19 MAY 2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC.. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY." } ], "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": "05/19/2020;06/24/2020" } ] }