FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3913687
·
Received June 30, 2014
Report
- Report Number
- MW5037056
- Event Type
- Injury
- Date Received
- June 30, 2014
- Report Date
- June 27, 2014
- Manufacturer
- CONCEPTUS, INC
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I WAS IMPLANTED WITH THE ESSURE COILS FOR PERMANENT STERILIZATION IN 2005 AFTER THAT I HAVE DEVELOPED A LARGE DERMOID CYST ON MY RIGHT OVARY. HAVE AN ECTOPIC PREGNANCY, BAD CRAMPS, MISSED PERIOD, HEAVY BLEEDING AND MIGRAINES. LOSS OF FEELING IN PELVIC AREA (TINGLING SENSATIONS) LOSS OF SEX DRIVE. SWELLING IN ABDOMEN, HUGE BLOOD CLOTHS DURING PERIOD. DIZZINESS, LIGHT HEADED AND BALANCE PROBLEMS. REOCCURRING YEAST INFECTIONS, FREQUENT URINATION, MOOD SWINGS, DEPRESSION, NO ENERGY. IT HAS TAKEN AWAY THE QUALITY OF MY LIFE AND IM ONLY (B)(6)!
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379152 | ESSURE | ESSURE | HHS | CONCEPTUS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Disability |