FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 4883659
·
Received June 25, 2015
Report
- Report Number
- MW5043371
- Event Type
- Injury
- Date Received
- June 25, 2015
- Date of Event
- June 28, 2015
- Report Date
- June 25, 2015
- Manufacturer
- BATYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD THE ESSURE PUT IN, IN 2010. I HAVE VERY SEVERE PAINS WHEN I'M ABOUT TO START MY PERIOD AND WHILE ON MY PERIOD. I'VE NOTICED IF I MOVE CERTAIN WAYS IT WILL PUNCH OR FEEL LIKE A STABBING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410801 | ESSURE | ESSURE | HHS | BATYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |