FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 4891993
·
Received July 6, 2015
Report
- Report Number
- MW5043489
- Event Type
- Injury
- Date Received
- July 6, 2015
- Date of Event
- May 18, 2015
- Report Date
- November 17, 2014
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). CHRONIC EXCRUCIATING PAIN ON LEFT SIDE, EXCRUCIATING MENSTRUAL CYCLES, HEAVY BLEEDING AND CLOTTING, NIGHT SWEATS, INSOMNIA, VOMITING, UNABLE TO WORK AND CARE FOR MY FAMILY REGULARLY, MIGRAINES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436525 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39.000 YR |