{ "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": 5468832 } }, "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": "2951250-2020-05646", "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": "464705", "implant_date_year": "2007", "date_removed_year": "2019", "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 answer provided", "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": "04/16/2020;08/25/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "No Code Available", "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": "10000018", "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": "190490424", "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 ('I AM 4 WEEKS PO') IN A (B)(6) 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 ARTHRALGIA (\"JOINT PAIN\"), JOINT SWELLING (\"I AM STILL SWOLLEN\") AND PRODUCTIVE COUGH (\"COUGHING UP FLEM\"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, JOINT SWELLING AND PRODUCTIVE COUGH OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ARTHRALGIA, JOINT SWELLING, MEDICAL DEVICE REMOVAL AND PRODUCTIVE COUGH TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL, ARTHRALGIA, JOINT SWELLING, PRODUCTIVE COUGH. 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": "320138297", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('I AM 4 WEEKS PO/PAIN') IN A 48-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA (\"JOINT PAIN\"), JOINT SWELLING (\"I AM STILL SWOLLEN\"), PRODUCTIVE COUGH (\"COUGHING UP FLEM\"), AUTOIMMUNE DISORDER (\"AUTOIMMUNE LIKE SYMPTOMS\"), DECREASED INTEREST (\"LOSS OF BEING ACTIVE DUE TO PAIN\"), FATIGUE (\"FATIGUE\"), ABDOMINAL PAIN (\"ABDOMINAL PAIN\"), MENSTRUATION IRREGULAR (\"IRREGULAR PERIODS\") AND GENITAL HAEMORRHAGE (\"BLEEDING\"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, JOINT SWELLING, PRODUCTIVE COUGH, AUTOIMMUNE DISORDER, DECREASED INTEREST, FATIGUE, ABDOMINAL PAIN, MENSTRUATION IRREGULAR AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, AUTOIMMUNE DISORDER, DECREASED INTEREST, FATIGUE, GENITAL HAEMORRHAGE, JOINT SWELLING, MENSTRUATION IRREGULAR, PELVIC PAIN AND PRODUCTIVE COUGH TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL, ARTHRALGIA, JOINT SWELLING, PRODUCTIVE COUGH. 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." }, { "mdr_text_key": "318290880", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('I AM 4 WEEKS PO/PAIN') IN A 48-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA (\"JOINT PAIN\"), JOINT SWELLING (\"I AM STILL SWOLLEN\"), PRODUCTIVE COUGH (\"COUGHING UP FLEM\"), DECREASED INTEREST (\"LOSS OF BEING ACTIVE DUE TO PAIN\"), FATIGUE (\"FATIGUE\"), ABDOMINAL PAIN (\"ABDOMINAL PAIN\"), MENSTRUATION IRREGULAR (\"IRREGULAR PERIODS\") AND GENITAL HAEMORRHAGE (\"BLEEDING\"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, JOINT SWELLING, PRODUCTIVE COUGH, DECREASED INTEREST, FATIGUE, ABDOMINAL PAIN, MENSTRUATION IRREGULAR AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, DECREASED INTEREST, FATIGUE, GENITAL HAEMORRHAGE, JOINT SWELLING, MENSTRUATION IRREGULAR, PELVIC PAIN AND PRODUCTIVE COUGH TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL, ARTHRALGIA, JOINT SWELLING, PRODUCTIVE COUGH. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-APR-2020: PFS RECEIVED- PT OF MEDICAL DEVICE REMOVAL UPDATED AS PELVIC PAIN FEMALE NEW EVENTS BLEEDING, AUTOIMMUNE LIKE SYMPTOMS, OTHER: LOSS OF BEING ACTIVE DUE TO PAIN AND FATIGUE, ABDOMINAL PAIN, IRREGULAR PERIODS WERE ADDED. REPORTERS 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." } ], "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": "05/06/2020;08/25/2020" } ] }