FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 4113547
·
Received September 24, 2014
Report
- Report Number
- MW5038266
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- March 22, 2013
- Report Date
- September 21, 2014
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
#MEDWATCHER #(B)(4). 1 MONTH AFTER HAVING ESSURE I STARTED GETTING SHARP STABBING PAINS ON MY LEFT SIDE THAT WAS CONSTANT, PASSED A FLESHY LOOKING CLOT THE LENGTH OF A PAD, HEAVY PAINFUL PERIODS, CONSTANTLY FATIGUED, JOINT PAINS, DIZZINESS, MORE HEADACHES
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595562 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23.000 YR | Other |