FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 6135355
·
Received November 30, 2016
Report
- Report Number
- MW5066396
- Event Type
- Injury
- Date Received
- November 30, 2016
- Date of Event
- October 13, 2010
- Report Date
- November 22, 2016
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4) STRONG METAL ODOR, HORRIBLE MENSTRUAL CRAMPS, MIGRAINES, CONSTANT BLOATING, BACK PAIN, MUSCLE STIFFNESS, FOG MEMORY, LOW VITAMIN D, LOW IRON, DEPRESSION, MUSCLE CRAMPS, MISSED PERIODS, MULTIPLE PERIODS IN A MONTH, HEAVY MENSTRUAL, PAIN DURING SEX, LOW ENERGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785021 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31.000 YR | Other |