{ "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": 65191 } }, "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": "2210968-2020-03474", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K061533", "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": [ "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": "463793", "implant_date_year": "2015", "date_removed_year": "2016", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "PVP SMALL 4.3CM X 4.3CM", "generic_name": "MESH, SURGICAL, POLYMERIC", "manufacturer_d_name": "ETHICON INC.", "manufacturer_d_address_1": "P.O. BOX 151, ROUTE 22 WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "SOMERVILLE", "manufacturer_d_state": "NJ", "manufacturer_d_zip_code": "08876", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "08876", "device_operator": "HEALTH PROFESSIONAL", "model_number": "PVPS", "catalog_number": "PVPS", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10705031132412", "udi_public": "10705031132412", "openfda": { "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Inflammation", "Hernia", "Adhesion(s)", "Inflammation", "Hernia" ] } ], "distributor_city": "", "date_report": "20200423", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000467", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200421", "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": "190308748", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM." }, { "mdr_text_key": "190308749", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT EPIGASTRIC HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2016 DURING WHICH THE SURGEON NOTED THE HERNIA DEFECT PUSHED THE MESH THROUGH THE DEFECT. THE HERNIA CONTENTS WERE DISSECTED FREE FROM THE CONNECTIVE TISSUE AND IT WAS EXCISED. ADHESIONS OF THE ANTERIOR ABDOMINAL WALL WERE TAKEN DOWN AND THE REMAINING DEFECT WAS REPAIRED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, ADHESIONS, LOSS OF APPETITE, STRESS AND ANXIETY. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION IS PROVIDED." } ], "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": "" } ] }