ESSURE
Report
- Report Number
- 2951250-2018-00468
- Event Type
- Injury
- Date Received
- January 24, 2018
- Date of Event
- February 1, 2013
- Report Date
- August 16, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN, PAIN") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927081, 927081) 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(S):NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED GONORRHEA, DYSFUNCTIONAL UTERINE BLEEDING, NAUSEA, VOMITING, VAGINAL ODOR, DIZZINESS, VAGINAL DISCHARGE, BACTERIAL VAGINOSIS, TENDERNESS, CONSTIPATION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED AZITHROMYCIN (ZITHROMAX), CEFTRIAXONE (ROCEPHIN), CILEST (ORTHO TRI-CYCLEN), CITALOPRAM HYDROBROMIDE (CELEXA), DIAZEPAM, DICLOFENAC, FLUCONAZOLE (DIFLUCAN), METRONIDAZOLE, METRONIDAZOLE (FLAGYL), METRONIDAZOLE (METROGEL), ONDANSETRON, ONDANSETRON (ZOFRAN), OXYBUTYNIN, SALBUTAMOL SULFATE (PROAIR HFA), SULFAMETHOXAZOLE AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION: URINARY TRACT INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2017 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (PER PFS)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE GENITAL HAEMORRHAGE AND PROCEDURAL PAIN WAS RESOLVING AND THE DYSMENORRHOEA AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PROCEDURAL PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: POSITIVE GONORRHEA TEST. HERE A FEW DAYS AGO, CALLED TO RETURN FOR TREATMENT. ROCEPHIN GIVEN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA VAGINAL BLEEDING, LOW ABDOMINAL PAIN ,ABDOMINAL CRAMPING ,ABDOMINAL PAIN ,DYSPAREUNIA,DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MEDICAL RECORD RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. CONCOMITANT DISEASE, CONCOMITANT DRUG,LAB DATA WERE ADDED. UPDATED SUSPECT DRUG INDICATION. EVENTS VAGINAL BLEEDING, MENORRHAGIA, DYSMENORRHEA, URINARY TRACT INFECTION,CRAMPING, ESSURE CONFIRMATION TEST(S):NO ADDED FROM PFS. 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 ("PELVIC PAIN, PAIN") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927081) 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(S):NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED GONORRHEA, DYSFUNCTIONAL UTERINE BLEEDING, NAUSEA, VOMITING, VAGINAL ODOR, DIZZINESS, VAGINAL DISCHARGE, BACTERIAL VAGINOSIS, ADNEXA UTERI PAIN, CONSTIPATION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED AZITHROMYCIN (ZITHROMAX), CEFTRIAXONE (ROCEPHIN), CILEST (ORTHO TRI-CYCLEN), CITALOPRAM HYDROBROMIDE (CELEXA), DIAZEPAM, DICLOFENAC, FLUCONAZOLE (DIFLUCAN), METRONIDAZOLE, METRONIDAZOLE (FLAGYL), METRONIDAZOLE (METROGEL), ONDANSETRON, ONDANSETRON (ZOFRAN), OXYBUTYNIN, SALBUTAMOL SULFATE (PROAIR HFA), SULFAMETHOXAZOLE AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN MAY 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN JUNE 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN JANUARY 2017, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION: URINARY TRACT INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (B)(6)2017 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (PER PFS)). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE GENITAL HAEMORRHAGE AND PROCEDURAL PAIN WAS RESOLVING AND THE DYSMENORRHOEA AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PROCEDURAL PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: POSITIVE GONORRHEA TEST. HERE A FEW DAYS AGO, CALLED TO RETURN FOR TREATMENT. ROCEPHIN GIVEN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA VAGINAL BLEEDING, LOW ABDOMINAL PAIN ,ABDOMINAL CRAMPING ,ABDOMINAL PAIN ,DYSPAREUNIA,DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: QUALITY SAFETY EVALUATION OF PTC. 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 ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, ABDOMINAL PAIN AND PROCEDURAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, PELVIC PAIN AND PROCEDURAL 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 |
|---|---|---|---|---|---|---|---|
| 59058 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 927081, 927081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other| R | AMBIEN| AMBIEN| CELEXA| CELEXA| DIAZEPAM| DIAZEPAM| DICLOFENAC| DICLOFENAC| DIFLUCAN| DIFLUCAN| FLAGYL| FLAGYL| METROGEL| METROGEL| METRONIDAZOLE| METRONIDAZOLE| ONDANSETRON| ONDANSETRON| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| OXYBUTYNIN| OXYBUTYNIN| PROAIR HFA| PROAIR HFA| ROCEPHIN| ROCEPHIN| SULFAMETHOXAZOLE| SULFAMETHOXAZOLE| ZITHROMAX| ZITHROMAX| ZOFRAN| ZOFRAN |