FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3944669
·
Received July 14, 2014
Report
- Report Number
- MW5037291
- Event Type
- Injury
- Date Received
- July 14, 2014
- Report Date
- July 11, 2014
- Manufacturer
- ESSURE
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
EIGHT YEARS AGO, ESSURE WRECKED MY LIFE. I HAVE CONSTANT HEADACHES, BODY ACHES, HIP PAIN, AWFUL PERIODS WITH NASTY PAIN, RINGING IN EARS AND HUGE WEIGHT GAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410065 | ESSURE | ESSURE | HHS | ESSURE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other| S |