{ "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": 98753 } }, "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": "2951250-2020-05665", "type_of_report": [ "Initial submission" ], "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": [ "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": "466237", "implant_date_year": "2004", "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": "ESS205", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HHS", "device_age_text": "", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": [ "Other", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000124", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20151101", "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": "194201344", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: (B)(4) ON (B)(6) 2015. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HEADACHE (\"HEADACHES\"), MENORRHAGIA (\"BAD 9 TO 15 DAYS LONG PERIODS\"), BACK PAIN (\"BACK PAIN\"), PAIN (\"BODY ACHES\"), ALOPECIA (\"LOSS OF HAIR\"), LOOSE TOOTH (\"ALMOST ALL HER TEETH WERE LOOSE\"), PELVIC PAIN (\"PELVIC PAINS\"), NAUSEA (\"HEADACHES GOT SO BAD SHE FELT SHE WAS GOING TO VOMIT WITH EVERY STEP\") AND RESTLESS LEGS SYNDROME (\"RESTLESS LEG\"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HEADACHE, MENORRHAGIA, BACK PAIN, PAIN, ALOPECIA, LOOSE TOOTH, PELVIC PAIN AND NAUSEA OUTCOME WAS UNKNOWN AND THE RESTLESS LEGS SYNDROME HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, HEADACHE, LOOSE TOOTH, MEDICAL DEVICE REMOVAL, MENORRHAGIA, NAUSEA, PAIN, PELVIC PAIN AND RESTLESS LEGS SYNDROME TO BE RELATED TO ESSURE (ESS205). QUALITY-SAFETY EVALUATION OF PTC: QUALITY ASSESSMENT: IN THIS CASE, NO PRODUCT SAMPLE 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. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME BECAUSE THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED EVENT(S) AND A QUALITY DEFECT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED. NEW REPORTERS ADDED. NEW EVENTS 'MEDICAL DEVICE REMOVAL' AND 'RESTLESS LEG' ADDED. UPON INTERNAL REVIEW, SUSPECT PRODUCT WAS RE-CODED. 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": "" } ] }