FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3891919
·
Received June 24, 2014
Report
- Report Number
- MW5036760
- Event Type
- Injury
- Date Received
- June 24, 2014
- Date of Event
- May 1, 2014
- Report Date
- October 16, 2015
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). GOT ESSURE TAKE OUT IN (B)(6) 2015, LEFT COIL WAS IMPROPERLY PLACED. TUBES REMOVED. I FEEL SO MUCH BETTER. NO CRAMPING AND I HAVE A LOT OF ENERGY. I AM STARTING TO LOSE WEIGHT AND THE PRESSURE FEELING IS GONE. I CAN FEEL THE CHANGE IN MY BODY. I FEEL LIKE ME AGAIN.
Description of Event or Problem · 1
WEIGHT GAIN, MIGRAINES, CRAMPING IN LOWER ABDOMEN, IRREGULAR MENSTRUAL CYCLES, PRESSURE CONSTANTLY IN LOWER ABDOMEN, FREQUENT SHARP PAIN NEAR HIPS, NAUSEA, SKIN RASH, DRY SKIN. FATIGUE, LOSS OF LIBIDO, STOMACH CRAMPING. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368740 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28.000 YR | Congenital Anomaly| H| L| O| S |