ESSURE
Report
- Report Number
- 2951250-2019-00973
- Event Type
- Injury
- Date Received
- March 4, 2019
- Report Date
- October 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. 893928-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND PARITY. 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), GENITAL HAEMORRHAGE ("BLEEDING /UNUSUAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THIS LOT 893928 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893928-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND PARITY. 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), GENITAL HAEMORRHAGE ("BLEEDING /UNUSUAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2020: PLAINTIFF FACT SHEET RECEIVED : NEW EVENT ABDOMINAL PAIN AND CRAMPING WAS 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893928-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND PARITY. 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), GENITAL HAEMORRHAGE ("BLEEDING /UNUSUAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("UNUSUAL PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, HEADACHE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONFIRMED POU YES ( AS REPORTED). THIS LOT 893928 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-2020: PLAINTIFF FACT SHEET RECEIVED. EVENT UNUSUAL PERIODS WAS ADDED. 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. 893928-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND PARITY. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAR-2019: UPDATE OF INFORMATION (BATCH IS INVALID). 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-CONFORMANCES 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") AND GENITAL HAEMORRHAGE ("BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893928) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND PARITY. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. AMENDMENT: THE REPORT WAS AMENDED ON (B)(6) 2019 FOR THE FOLLOWING REASON: SIGNIFICANT CORRECTION. MENORRHAGIA CHANGED FROM INCIDENT TO OTHER EVENT. UNTICKED MEDICALLY SIGNIFICANT FOR MENORRHAGIA. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 |
|---|---|---|---|---|---|---|---|
| 181539 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893928-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |