ESSURE
Report
- Report Number
- 2951250-2018-01487
- Event Type
- Injury
- Date Received
- April 5, 2018
- Date of Event
- January 1, 2014
- Report Date
- September 25, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("MENORRHAGIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C76434, C76456 -NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST CONDUCTED-NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY IN (B)(6) 2014, UTERINE BLEEDING AND HYSTERECTOMY (POSTOP HYSTEROSCOPY D&C) ON (B)(6) 2014. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILL NOS AND IMPLANON. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYN). IN 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA") AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH NAPROXEN, SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (OUTPATIENT HYSTEROSCOPY, D AND C AND BALLOON ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: (B)(6) 2014: THE HYSTEROSCOPY WAS WALKED THROUGH THE CERVIX TO THE UTERINE CAVITY. BOTH TUBAL OSTIA WERE SEEN IN NORMAL POSITION. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. DIAGNOSTIC RESULTS: ON (B)(6) 2014, HYSTEROSCOPY REVEILED. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. ON (B)(6) 2015, ULTRASOUND PELVIS SHOWED, SOME TRAPPED FLUID WITHIN THE ENDOMETRIUM IN THIS PATIENT STATUS POST REPORTED ENDOMETRIAL ABLATION. SLIGHT COMPLEX LIKELY FOLLICULAR CYST IN THE RIGHT OVARY. C76434, C76456 ARE NOT VALID LOT NUMBERS QUALITY-SAFETY EVALUATION OF PTC: C76434, C76456 NOT VALID LOT NUMBERS: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH IS NOT VALID) INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C76434, C76456) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST CONDUCTED-NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY IN (B)(6) 2014, UTERINE BLEEDING AND HYSTERECTOMY (POSTOP HYSTEROSCOPY D&C) ON (B)(6) 2014. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILL NOS AND IMPLANON. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYN). ON (B)(6) 2014, 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), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA") AND MENORRHAGIA ("MENORRHAGIA") (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (OUTPATIENT HYSTEROSCOPY, D AND C AND BALLOON ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: (B)(6) 2014: THE HYSTEROSCOPY WAS WALKED THROUGH THE CERVIX TO THE UTERINE CAVITY. BOTH TUBAL OSTIA WERE SEEN IN NORMAL POSITION. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. DIAGNOSTIC RESULTS: ON (B)(6) 2014, HYSTEROSCOPY REVEILED. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. ON (B)(6) 2015, ULTRASOUND PELVIS SHOWED, SOME TRAPPED FLUID WITHIN THE ENDOMETRIUM IN THIS PATIENT STATUS POST REPORTED ENDOMETRIAL ABLATION. SLIGHT COMPLEX LIKELY FOLLICULAR CYST IN THE RIGHT OVARY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAR-2018: MEDICAL RECORD RECEIVED. NEW REPORTERS ADDED. PLAINTIFF¿S DEMOGRAPHICS AND RELEVANT HISTORY ADDED. NEW LOT NUMBER ADDED. LAB DATA AND HISTORICAL CONDITION ADDED. IT WAS REPORTED THAT OUTPATIENT HYSTEROSCOPY, D AND C AND BALLOON ABLATION WAS PERFORMED FOR SEVERE MENORRHAGIA. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("MENORRHAGIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. (B)(4)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST CONDUCTED-NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY IN OCTOBER 2014, UTERINE BLEEDING AND HYSTERECTOMY (POSTOP HYSTEROSCOPY D&C) ON (B)(6) 2014. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILL NOS AND IMPLANON. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYN). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA") AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH NAPROXEN, SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (OUTPATIENT HYSTEROSCOPY, D AND C AND BALLOON ABLATION ON 18-DEC-2015). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: (B)(6) 2014: THE HYSTEROSCOPY WAS WALKED THROUGH THE CERVIX TO THE UTERINE CAVITY. BOTH TUBAL OSTIA WERE SEEN IN NORMAL POSITION. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. DIAGNOSTIC RESULTS: ON (B)(6) 2014, HYSTEROSCOPY REVEILED. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. ON (B)(6) 2015, ULTRASOUND PELVIS SHOWED, SOME TRAPPED FLUID WITHIN THE ENDOMETRIUM IN THIS PATIENT STATUS POST REPORTED ENDOMETRIAL ABLATION. SLIGHT COMPLEX LIKELY FOLLICULAR CYST IN THE RIGHT OVARY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-MAY-2018: PFS AND MR RECEIVED: EVENT ADDED:LOWER BACK PAIN. OUTCOME OF SOME EVENTS UPDATED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("MENORRHAGIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C76434-INV, C76456) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST CONDUCTED-NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY IN (B)(6) 2014, UTERINE BLEEDING AND HYSTERECTOMY (POSTOP HYSTEROSCOPY D&C) ON (B)(6) 2014. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILL NOS AND IMPLANON. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYN). IN 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA/PAINFUL PERIODS/DYSMENORRHEA (CRAMPING),") AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH NAPROXEN, SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)) AND SURGERY (OUTPATIENT HYSTEROSCOPY, D AND C AND BALLOON ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: (B)(6) 2014: THE HYSTEROSCOPY WAS WALKED THROUGH THE CERVIX TO THE UTERINE CAVITY. BOTH TUBAL OSTIA WERE SEEN IN NORMAL POSITION. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. DIAGNOSTIC RESULTS: ON (B)(6) 2014, HYSTEROSCOPY REVEILED. THE ESSURE DEVICES WERE OPENED AND THE ESSURE DEVICE WAS EASILY PLACED IN THE RIGHT AND LEFT TUBAL OSTIA. ON (B)(6) 2015, ULTRASOUND PELVIS SHOWED, SOME TRAPPED FLUID WITHIN THE ENDOMETRIUM IN THIS PATIENT STATUS POST REPORTED ENDOMETRIAL ABLATION. SLIGHT COMPLEX LIKELY FOLLICULAR CYST IN THE RIGHT OVARY. LOT NUMBER: C76434 IS INVALID. LOT NUMBER:C76456 IS VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C76434) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST CONDUCTED-NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY IN (B)(6) 2014. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILL NOS AND IMPLANON. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYN). ON (B)(6) 2014, 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), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PLANTIFF FACT SHEET RECEIVED. EVENT INJURY NOS REPLACED WITH ABNORMAL BLEEDING, VAGINAL BLEEDING , MENORRHAGIA, DYSMENORRHEA PELVIC PAIN AND ESSURE CONFIRMATION TEST CONDUCTED-NO ARE ADDED. LOT NUMBER ADDED. LAB DATA UPDATED. CONCOMITANT CONDITIONS AND DRUGS ARE ADDED. PRODUCT , PATIENT & REPORTER INFORMATION UPDATED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY INCIDENT. AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241900 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C76434-INV, C76456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | NAPROSYN| NAPROSYN| NAPROSYN| NAPROSYN| NAPROSYN| NAPROSYN |