FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3884984
·
Received June 19, 2014
Report
- Report Number
- MW5036677
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- November 29, 2013
- Report Date
- May 29, 2014
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ABDOMINAL PAIN, PERIODS STARTED BECOMING IRREGULAR, HEAVY, AND PAINFUL, CHRONIC FATIGUE, HEADACHES, SOME JOINT PAIN AND HEAVY BLEEDING DURING SEX. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361898 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43.000 YR | Other | WATER PILL |