ESSURE
Report
- Report Number
- 2951250-2017-02909
- Event Type
- Injury
- Date Received
- August 15, 2017
- Report Date
- June 18, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: NUVA RING IN 2005. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, OVARIAN CYST, BLADDER INFECTION AND DRUG ALLERGY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING"), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), URTICARIA ("HIVES"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITHOUT SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, MENORRHAGIA, DYSPAREUNIA, URTICARIA, GENITAL HAEMORRHAGE, DYSMENORRHOEA, FATIGUE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND URTICARIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT HER SYMPTOMS WERE NOT RELIEVED FOLLOWING THIS PROCEDURE AND SHE WAS SEEKING LAPAROSCOPIC BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE COILS FROM HER BODY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAR-2018: PLAINTIFF FACT SHEET & MEDICAL RECORD RECEIVED. EVENTS ABNORMAL BLEEDING, DYSMENORRHEA, PELVIC PAIN, ARE ADDED. CONCOMITANT & HISTORICAL CONDITIONS & DRUGS ARE ADDED. LOT NUMBER ADDED. LAB DATA UPDATED. PRODUCT, PATIENT & REPORTER INFORMATION 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: NUVA RING IN 2005. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, OVARIAN CYST, BLADDER INFECTION AND DRUG ALLERGY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), URTICARIA ("HIVES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITHOUT SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, URTICARIA, DYSMENORRHOEA, FATIGUE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND URTICARIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT HER SYMPTOMS WERE NOT RELIEVED FOLLOWING THIS PROCEDURE AND SHE WAS SEEKING LAPAROSCOPIC BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE COILS FROM HER BODY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUL-2018: QUALITY DEPARTMENT CONFIRMED LOT NUMBER IS INVALID - NO UPDATE OF PTC INVESTIGATION WILL BE PERFORMED. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 INVALID) 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 "SHE DIDN¿T UNDERGO ESSURE CONFIRMATION TEST.". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: NUVA RING IN 2005. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, OVARIAN CYST, BLADDER INFECTION AND DRUG ALLERGY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), URTICARIA ("HIVES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITHOUT SALPINGECTOMY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, URTICARIA, DYSMENORRHOEA, FATIGUE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND URTICARIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT HER SYMPTOMS WERE NOT RELIEVED FOLLOWING THIS PROCEDURE AND SHE WAS SEEKING LAPAROSCOPIC BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE COILS FROM HER BODY. AS PER PFS SHE DID NOT REMOVE ESSURE, CURRENTLY PLANNING FOR ESSURE REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2018: PFS RECEIVED- NEW EVENT SHE DIDN¿T UNDERGO ESSURE CONFIRMATION TEST WERE ADDED. 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 ABDOMINAL PAIN ('ABDOMINAL PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 INVALID) 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 "SHE DIDN¿T UNDERGO ESSURE CONFIRMATION TEST.". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: NUVA RING. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, OVARIAN CYST, BLADDER INFECTION AND DRUG ALLERGY. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE. IN MAY 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY MENSTRUAL PERIODS/ ABNORMAL BLEEDING (MENORRHAGIA"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), PELVIC PAIN ("PAIN") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING/ LOWER ABDOMINAL PAIN") AND URTICARIA ("HIVES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITHOUT SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, MENORRHAGIA, DYSPAREUNIA, URTICARIA, DYSMENORRHOEA, FATIGUE, PELVIC PAIN AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT HER SYMPTOMS WERE NOT RELIEVED FOLLOWING THIS PROCEDURE AND SHE WAS SEEKING LAPAROSCOPIC BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE COILS FROM HER BODY. AS PER PFS SHE DID NOT REMOVE ESSURE, CURRENTLY PLANNING FOR ESSURE REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2019: PLAINTIFF FACT SHEET WAS RECEIVED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL). AND EVENT- "LOWER ABDOMEN PAIN CLUBBED TO PREVIOUS EVENT- CRAMPING". SEVERITY, EVENTS ONSET DATE WERE ADDED. 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
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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 ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING"), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE") AND URTICARIA ("HIVES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITHOUT SALPINGECTOMY). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, MENORRHAGIA, DYSPAREUNIA AND URTICARIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, MENORRHAGIA AND URTICARIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT HER SYMPTOMS WERE NOT RELIEVED FOLLOWING THIS PROCEDURE AND SHE WAS SEEKING LAPAROSCOPIC BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE COILS FROM HER BODY. 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 |
|---|---|---|---|---|---|---|---|
| 575144 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955816 INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | HYDROCODONE |