{ "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": 6038961 } }, "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": "2951250-2020-05647", "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": "464704", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/18/2020;08/25/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "No Code Available", "Abdominal Pain", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200825", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000016", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200323", "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": "319338492", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ('CRAMPS') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH (\"RASH ON BUTT CHEEK\") AND RASH MACULAR (\"RED DOTS ON INNER THIGH ,BELLY ,LEGS, NOSE \"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER AND RASH MACULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, RASH AND RASH MACULAR TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2020: SOCIAL MEDIA RECEIVED: NEWLY ADDED EVENTS- RED BLOTCHES, REPORTER WAS ADDED. MEDICAL DEVICE REMOVAL EVENT WAS DELETED. 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": "189592180", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ABDOMINAL PAIN LOWER (\"CRAMPS\") AND RASH (\"RASH ON BUTT CHEEK\"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERCTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, MEDICAL DEVICE REMOVAL AND RASH TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- RASH, ABDOMINAL PAIN LOWER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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": "318665802", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ('CRAMPS') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH (\"RASH ON BUTT CHEEK\") AND RASH MACULAR (\"RED DOTS ON INNER THIGH ,BELLY ,LEGS, NOSE \"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERCTOMY). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER AND RASH MACULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, RASH AND RASH MACULAR TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. 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": "07/13/2020;08/25/2020" } ] }