{ "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. 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THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN AND HIP FRACTURE. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6)2011. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NUMBER OF PROXIMAL COILS 5 ON LEFT CORNUA AND 7 ON RIGHT CORNUA CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- -GET IT OUT,LOST IN ABDOMEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." }, { "mdr_text_key": "316005738", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('GET IT OUT') 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 CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED DEVICE DISLOCATION (\"LOST IN ABDOMEN\"). THE REPORTER CONSIDERED DEVICE DISLOCATION AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- -GET IT OUT,LOST IN ABDOMEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUN-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." }, { "mdr_text_key": "189592754", "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 ('GET IT OUT') 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 CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED DEVICE DISLOCATION (\"LOST IN ABDOMEN\"). THE REPORTER CONSIDERED DEVICE DISLOCATION AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- -GET IT OUT, LOST IN ABDOMEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." }, { "mdr_text_key": "319233397", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('LOST IN ABDOMEN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 752413) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN AND HIP FRACTURE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NUMBER OF PROXIMAL COILS 5 ON LEFT CORNUA AND 7 ON RIGHT CORNUA . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- GET IT OUT,LOST IN ABDOMEN . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-JUN-2020: MEDICAL RECORD RECEIVED LOT NUMBER WAS ADDED. REPORTER INFORMATION, MEDICAL HISTORY WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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": "06/30/2020;07/22/2020;08/14/2020" } ] }