ESSURE
Report
- Report Number
- 2951250-2017-09480
- Event Type
- Injury
- Date Received
- November 30, 2017
- Date of Event
- April 1, 2013
- Report Date
- August 21, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING / ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 120520) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GALLBLADDER OPERATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEXAPRO FROM 2012 TO (B)(6) 2018, WELLBUTRIN FROM 2012 TO (B)(6) 2018 AND BIRTH CONTROL PILL FROM 2008 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED SPOTTING VAGINAL AND CHRONIC CERVICITIS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (A PELVIC SURGERY / LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, NAUSEA AND DYSFUNCTIONAL UTERINE BLEEDING HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSFUNCTIONAL UTERINE BLEEDING, GENITAL HAEMORRHAGE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO OSTIA WERE OBVIOUSLY PRESENT AND PLACED ESSURE WHERE THERE WERE ABOUT THREE COILS ON EACH SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: FULL OCCLUSION OF BOTH FALLOPIAN TUBES CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: GENITAL HAEMORRHAGE , NAUSEA, PELVIC PAIN FEMALE,DYSFUNCIONAL UTERINE BLEEDING". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2018: PFS RECEIVED: OUTCOME FOR THE EVENT ABDOMINAL PAIN LOWER UPDATED TO RECOVERED / RESOLVED . 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 ("CHRONIC PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING / ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 120520) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GALLBLADDER OPERATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEXAPRO FROM 2012 TO (B)(6) 2018, WELLBUTRIN FROM 2012 TO (B)(6) 2018 AND BIRTH CONTROL PILL FROM 2008 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED SPOTTING VAGINAL AND CHRONIC CERVICITIS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMEN PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (A PELVIC SURGERY / LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, NAUSEA AND DYSFUNCTIONAL UTERINE BLEEDING HAD RESOLVED AND THE ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSFUNCTIONAL UTERINE BLEEDING, GENITAL HAEMORRHAGE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO OSTIA WERE OBVIOUSLY PRESENT AND PLACED ESSURE WHERE THERE WERE ABOUT THREE COILS ON EACH SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: FULL OCCLUSION OF BOTH FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: GENITAL HAEMORRHAGE , NAUSEA, PELVIC PAIN FEMALE,DYSFUNCTIONAL UTERINE BLEEDING". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2018: PFS AND MEDICAL RECORDS RECEIVED - NEW EVENTS "NAUSEA, ABDOMEN PAIN" AND" DYSFUNCTIONAL UTERINE BLEEDING" WERE ADDED. LOT NUMBER WAS ADDED. PRODUCT IMPLANT AND EXPLANT DATE WAS ADDED. LAB DATA WAS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS WERE ADDED. NEW REPORTER WERE ADDED. 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 ("CHRONIC PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING / ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 120520-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GALLBLADDER OPERATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEXAPRO FROM (B)(6) TO (B)(6)2018, WELLBUTRIN FROM (B)(6) TO (B)(6)2018 AND BIRTH CONTROL PILL FROM (B)(6) TO (B)(6)2013. CONCURRENT CONDITIONS INCLUDED SPOTTING VAGINAL AND CHRONIC CERVICITIS. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (A PELVIC SURGERY / LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, NAUSEA AND DYSFUNCTIONAL UTERINE BLEEDING HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSFUNCTIONAL UTERINE BLEEDING, GENITAL HAEMORRHAGE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO OSTIA WERE OBVIOUSLY PRESENT AND PLACED ESSURE WHERE THERE WERE ABOUT THREE COILS ON EACH SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: FULL OCCLUSION OF BOTH FALLOPIAN TUBES CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: GENITAL HAEMORRHAGE , NAUSEA, PELVIC PAIN FEMALE,DYSFUNCIONAL UTERINE BLEEDING". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-2018: UPDATE OF INFORMATION (BATCH IS INVALID) INCIDENT NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT HAD ESSURE INSERTED. IN THE SAME YEAR, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (A PELVIC SURGERY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 |
|---|---|---|---|---|---|---|---|
| 850206 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 120520-INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R |