ESSURE
Report
- Report Number
- 2951250-2019-00890
- Event Type
- Injury
- Date Received
- March 1, 2019
- Report Date
- August 25, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D811320-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED ISCHEMIC COLITIS, CLOSTRIDIUM DIFFICILE INFECTION, MENORRHAGIA, BACK PAIN, HERNIA, LEFT LOWER QUADRANT PAIN AND MASS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING"), MENSTRUAL DISORDER ("UNUSUAL PERIODS"), MENORRHAGIA ("MENORRHAGIA"), BACK PAIN ("BACK PAIN ") AND DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. LOT # REPORTED (D811320) IS NOT VALID. 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 PRODUCT TECHNICAL 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D811320-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED ISCHEMIC COLITIS, CLOSTRIDIUM DIFFICILE INFECTION, MENORRHAGIA, BACK PAIN, HERNIA, LEFT LOWER QUADRANT PAIN AND MASS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING"), MENSTRUAL DISORDER ("UNUSUAL PERIODS"), MENORRHAGIA ("MENORRHAGIA"), BACK PAIN ("BACK PAIN ") AND DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2020: PFS RECEIVED. NEW EVENTS: MENORRHAGIA, BACK PAIN, DYSMENORRHEA WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D811320-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED ISCHEMIC COLITIS, CLOSTRIDIUM DIFFICILE INFECTION, MENORRHAGIA, BACK PAIN, HERNIA, LEFT LOWER QUADRANT PAIN AND MASS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("UNUSUAL PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: NO VALID 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-CONFORMANT 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 ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D811320-INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED ISCHEMIC COLITIS, CLOSTRIDIUM DIFFICILE INFECTION, MENORRHAGIA, BACK PAIN, HERNIA, LEFT LOWER QUADRANT PAIN AND MASS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING"), MENSTRUAL DISORDER ("UNUSUAL PERIODS"), MENORRHAGIA ("MENORRHAGIA"), BACK PAIN ("BACK PAIN ") AND DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. LOT # REPORTED (D811320) IS NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D811320) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED ISCHEMIC COLITIS, CLOSTRIDIUM DIFFICILE INFECTION, MENORRHAGIA, BACK PAIN, HERNIA, LEFT LOWER QUADRANT PAIN AND MASS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("UNUSUAL PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175310 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D811320-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |