FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3900370
·
Received June 27, 2014
Report
- Report Number
- MW5036860
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- June 24, 2014
- Report Date
- June 24, 2014
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ALLERGIES, MIGRAINES, PAIN IN LOWER BACK, PAIN IN RIGHT SIDE OF THE ABDOMEN, HAIR LOSS, ACNE, GAIN WEIGHT, SWOLLEN FEET, MENSTRUAL PROBLEMS, DEPRESSION. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376625 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32.000 YR | Hospitalization| O| S |