ESSURE
Report
- Report Number
- 2951250-2019-11438
- Event Type
- Injury
- Date Received
- November 13, 2019
- Date of Event
- January 1, 2011
- Report Date
- July 7, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHROPATHY ("JOINT PROBLEMS"), FATIGUE ("TIREDNESS"), LISTLESS ("LISTLESSNESS") AND OVULATION PAIN ("VERY PAINFUL OVULATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN, ARTHROPATHY, FATIGUE, LISTLESS AND OVULATION PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHROPATHY, BACK PAIN, FATIGUE, LISTLESS AND OVULATION PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT IS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. LOT NUMBER:810886 MANUFACTURING DATE:2010-12 EXPIRATION DATE:2013-12 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUN-2020: QUALITY SAFETY EVALUATION OF PTC (BATCH INFORMATION). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHROPATHY ("JOINT PROBLEMS"), FATIGUE ("TIREDNESS"), LISTLESS ("LISTLESSNESS") AND OVULATION PAIN ("VERY PAINFUL OVULATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN, ARTHROPATHY, FATIGUE, LISTLESS AND OVULATION PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHROPATHY, BACK PAIN, FATIGUE, LISTLESS AND OVULATION PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT IS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: LOT NUMBER WAS ADDED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN / LOWER BACK PAIN') AND UTERINE PERFORATION ('DURING THE OPERATION, IT WAS FOUND THAT THE ESSURE HAD MIGRATED AND HAD ALSO PERFORATED UTERUS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("TIREDNESS"), OVULATION PAIN ("VERY PAINFUL OVULATION"), ABDOMINAL PAIN ("PAIN IN HER ABDOMEN"), PELVIC PAIN ("PAIN IN PELVIC AREA"), DYSMENORRHOEA ("PAIN DURING MENSTRUATION"), ARTHRALGIA ("JOINT PAIN"), ECZEMA ("ECZEMA"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), AMNESIA ("MEMORY LOSS") AND PSYCHIATRIC SYMPTOM ("PSYCHIATRIC SYMPTOMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS "). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2019, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 7 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHROPATHY ("JOINT PROBLEMS") AND LISTLESS ("LISTLESSNESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ALONG WITH FALLOPIAN TUBES AND PART OF UTERUS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE BACK PAIN, ABDOMINAL PAIN AND DYSMENORRHOEA HAD NOT RESOLVED AND THE UTERINE PERFORATION, ARTHROPATHY, FATIGUE, LISTLESS, OVULATION PAIN, PELVIC PAIN, ARTHRALGIA, ECZEMA, HYPERSENSITIVITY, AMNESIA, HORMONE LEVEL ABNORMAL AND PSYCHIATRIC SYMPTOM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, ARTHROPATHY, BACK PAIN, DYSMENORRHOEA, ECZEMA, FATIGUE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, LISTLESS, OVULATION PAIN, PELVIC PAIN, PSYCHIATRIC SYMPTOM AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THAT AFTER THE SURGERY, MANY OF THE SYMPTOMS DISAPPEARED. ESSURE LOT # 810886 MANUFACTURING RELEASE DATE REPORTED VIA LAWYER: (B)(6) 2011. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: IMDRF-FDA SYNCHRONIZATION. ESSURE LOT # 810886 MANUFACTURING RELEASE DATE REPORTED VIA LAWYER: (B)(6) 2011. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHROPATHY ("JOINT PROBLEMS"), FATIGUE ("TIREDNESS"), LISTLESS ("LISTLESSNESS") AND OVULATION PAIN ("VERY PAINFUL OVULATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN, ARTHROPATHY, FATIGUE, LISTLESS AND OVULATION PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHROPATHY, BACK PAIN, FATIGUE, LISTLESS AND OVULATION PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT IS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAY-2020: REPORT WAS NOW RECEIVED FROM LAWYER. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN') AND UTERINE PERFORATION ('DURING THE OPERATION, IT WAS FOUND THAT THE ESSURE HAD MIGRATED AND HAD ALSO PERFORATED UTERUS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("TIREDNESS"), OVULATION PAIN ("VERY PAINFUL OVULATION"), ABDOMINAL PAIN ("PAIN IN HER ABDOMEN "), PELVIC PAIN ("PAIN IN PELVIC AREA"), DYSMENORRHOEA ("PAIN DURING MENSTRUATION"), ARTHRALGIA ("JOINT PAIN"), ECZEMA ("ECZEMA"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), AMNESIA ("MEMORY LOSS") AND PSYCHIATRIC SYMPTOM ("PSYCHIATRIC SYMPTOMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS "). ON (B)(6) 2019, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 7 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHROPATHY ("JOINT PROBLEMS") AND LISTLESS ("LISTLESSNESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ALONG WITH FALLOPIAN TUBES AND PART OF UTERUS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE BACK PAIN, UTERINE PERFORATION, ARTHROPATHY, FATIGUE, LISTLESS, OVULATION PAIN, ABDOMINAL PAIN, PELVIC PAIN, DYSMENORRHOEA, ARTHRALGIA, ECZEMA, HYPERSENSITIVITY, AMNESIA, HORMONE LEVEL ABNORMAL AND PSYCHIATRIC SYMPTOM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, ARTHROPATHY, BACK PAIN, DYSMENORRHOEA, ECZEMA, FATIGUE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, LISTLESS, OVULATION PAIN, PELVIC PAIN, PSYCHIATRIC SYMPTOM AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE SURGERY, MANY OF THE SYMPTOMS DISAPPEARED. DESPITE THE FACT THAT SHE STILL OFTEN SUFFERS FROM PERSISTENT PAIN IN HER PELVIC REGION AND LOWER BACK, AND PAIN DURING MENSTRUATION, SHE IS STEADILY IMPROVING. LOT NUMBER:810886 MANUFACTURING DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-DEC-2020: REPORTER, ESSURE INDICATION, STOP DATE AND EVENTS PAIN IN ABDOMEN, PAIN IN PELVIC AREA, PAIN DURING MENSTRUATION, JOINT PAIN, ECZEMA, ALLERGIC REACTIONS, MEMORY LOSS, HORMONAL PROBLEMS, PSYCHIATRIC SYMPTOMS AND DURING THE OPERATION, IT WAS FOUND THAT THE ESSURE HAD MIGRATED AND HAD ALSO PERFORATED UTERUS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN / LOWER BACK PAIN') AND UTERINE PERFORATION ('DURING THE OPERATION, IT WAS FOUND THAT THE ESSURE HAD MIGRATED AND HAD ALSO PERFORATED UTERUS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("TIREDNESS"), OVULATION PAIN ("VERY PAINFUL OVULATION"), ABDOMINAL PAIN ("PAIN IN HER ABDOMEN"), PELVIC PAIN ("PAIN IN PELVIC AREA"), DYSMENORRHOEA ("PAIN DURING MENSTRUATION"), ARTHRALGIA ("JOINT PAIN"), ECZEMA ("ECZEMA"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), AMNESIA ("MEMORY LOSS") AND PSYCHIATRIC SYMPTOM ("PSYCHIATRIC SYMPTOMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS "). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2019, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 7 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHROPATHY ("JOINT PROBLEMS") AND LISTLESS ("LISTLESSNESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ALONG WITH FALLOPIAN TUBES AND PART OF UTERUS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE BACK PAIN, ABDOMINAL PAIN AND DYSMENORRHOEA HAD NOT RESOLVED AND THE UTERINE PERFORATION, ARTHROPATHY, FATIGUE, LISTLESS, OVULATION PAIN, PELVIC PAIN, ARTHRALGIA, ECZEMA, HYPERSENSITIVITY, AMNESIA, HORMONE LEVEL ABNORMAL AND PSYCHIATRIC SYMPTOM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, ARTHROPATHY, BACK PAIN, DYSMENORRHOEA, ECZEMA, FATIGUE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, LISTLESS, OVULATION PAIN, PELVIC PAIN, PSYCHIATRIC SYMPTOM AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THAT AFTER THE SURGERY, MANY OF THE SYMPTOMS DISAPPEARED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2020: THE ADVERSE EVENT LOWER BACK PAIN WAS PROVIDED AND THE OUTCOME FOR: BACK PAIN, PAIN IN HER ABDOMEN, PAIN DURING MENSTRUATION AND LOWER BACK PAIN WERE UPDATED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN / LOWER BACK PAIN') AND UTERINE PERFORATION ('DURING THE OPERATION, IT WAS FOUND THAT THE ESSURE HAD MIGRATED AND HAD ALSO PERFORATED UTERUS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 810886) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("TIREDNESS"), OVULATION PAIN ("VERY PAINFUL OVULATION"), ABDOMINAL PAIN ("PAIN IN HER ABDOMEN"), PELVIC PAIN ("PAIN IN PELVIC AREA"), DYSMENORRHOEA ("PAIN DURING MENSTRUATION"), ARTHRALGIA ("JOINT PAIN"), ECZEMA ("ECZEMA"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), AMNESIA ("MEMORY LOSS") AND PSYCHIATRIC SYMPTOM ("PSYCHIATRIC SYMPTOMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS "). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2019, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 7 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHROPATHY ("JOINT PROBLEMS") AND LISTLESS ("LISTLESSNESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ALONG WITH FALLOPIAN TUBES AND PART OF UTERUS). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE BACK PAIN, ABDOMINAL PAIN AND DYSMENORRHOEA HAD NOT RESOLVED AND THE UTERINE PERFORATION, ARTHROPATHY, FATIGUE, LISTLESS, OVULATION PAIN, PELVIC PAIN, ARTHRALGIA, ECZEMA, HYPERSENSITIVITY, AMNESIA, HORMONE LEVEL ABNORMAL AND PSYCHIATRIC SYMPTOM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, ARTHROPATHY, BACK PAIN, DYSMENORRHOEA, ECZEMA, FATIGUE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, LISTLESS, OVULATION PAIN, PELVIC PAIN, PSYCHIATRIC SYMPTOM AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THAT AFTER THE SURGERY, MANY OF THE SYMPTOMS DISAPPEARED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2020: THE ADVERSE EVENT LOWER BACK PAIN WAS PROVIDED AND THE OUTCOME FOR: BACK PAIN, PAIN IN HER ABDOMEN, PAIN DURING MENSTRUATION AND LOWER BACK PAIN WERE UPDATED. AMENDMENT: DUE TO INTERNAL REVIEW LAST FOLLOW UP WAS NOT RECEIVED ON 31-DEC-2020 BUT ON 16-DEC-2020. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHROPATHY ("JOINT PROBLEMS"), FATIGUE ("TIREDNESS"), LISTLESS ("LISTLESSNESS") AND OVULATION PAIN ("VERY PAINFUL OVULATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE BACK PAIN, ARTHROPATHY, FATIGUE, LISTLESS AND OVULATION PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHROPATHY, BACK PAIN, FATIGUE, LISTLESS AND OVULATION PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT IS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1108880 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810886 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |