ESSURE
Report
- Report Number
- 2951250-2019-07154
- Event Type
- Injury
- Date Received
- September 19, 2019
- Report Date
- September 22, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, MENORRHAGIA, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012 AND (B)(6) 2013 (DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2020: PLAINTIFF FACT SHEET WAS RECEIVED. LOT NUMBER WERE ADDED. EVENT ADDED FROM PFS- ABNORMAL BLEEDING (GENERAL), DYSMENORRHEA (CRAMPING). REPORTER INFORMATION, LAB DATA WERE ADDED. ESSURE INSERTION DATE WERE UPDATED. 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, MENORRHAGIA, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012 AND (B)(6) 2013(DISCREPANCY NOTED) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 922613 MANUFACTURE DATE: (B)(6) 2011 EXPIRATION DATE:(B)(6) 2014 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE BACK PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6)2012 AND (B)(6)2013(DISCREPANCY NOTED). DISCREPANCY ESSURE REMOVAL DATE: (B)(6)2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2013: SATISFACTORY POSITION OF ESSURE DEVICE WITH TUBAL OCCLUSION BILATERALLY; ON (B)(6)2013: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 922613 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-JUN-2020: PFS RECEIVED: EVENT OUTCOME OF GENITAL BLEEDING, DYSMENORRHEA, BACK PIN WERE UPDATED AS RECOVERED/RESOLVED. 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL HAEMORRHAGE ("VAGINAL HAEMORRHAGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE BACK PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012 AND (B)(6) 2013(DISCREPANCY NOTED). DISCREPANCY ESSURE REMOVAL DATE: (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: SATISFACTORY POSITION OF ESSURE DEVICE WITH TUBAL OCCLUSION BILATERALLY; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 922613, MANUFACTURE DATE: 2011-11, EXPIRATION DATE: 2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2020: PIF: RECEIVED VAGINAL HEMORRHAGE EVENT ADDED. 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, MENORRHAGIA AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2013 (DISCREPANCY NOTED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED. EVENTS: PAIN: BACK, PELVIC/ ABDOMINAL,MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), SEVERE CRAMPING WERE ADDED. INCIDENT: 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 |
|---|---|---|---|---|---|---|---|
| 883803 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922613 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |