FDA Adverse Event
Injury
Summary report: N
SEE HOSPITAL RECORDS
MDR report key: 2254767
·
Received September 13, 2011
Report
- Report Number
- MW5022253
- Event Type
- Injury
- Date Received
- September 13, 2011
- Date of Event
- June 1, 2010
- Report Date
- September 13, 2011
- Manufacturer
- SEE HOSPITAL RECORDS
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD MY UTERUS REMOVED IN (B)(6) 2008. THEY USED A TRANS-VAGINAL MESH. I BEGAN HAVING SEVERE PAIN AND EXTREME DIFFICULTY WITH ELIMINATION. I HAD A PROCEDURE TO CORRECT VAGINAL EROSION ON (B)(6) 2011 AT (B)(6) WITH NO RELIEF. I CAME BACK TO (B)(6) WHERE I HAD THE PARTIAL HYSTERECTOMY AND THEY HAVE NOW REFERRED ME TO (B)(6). I AM NOW LOOKING FOR A LAWYER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEE HOSPITAL RECORDS | TRANS-VAGINAL MESH | FTL | SEE HOSPITAL RECORDS | SEE HOSPITAL RECORDS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Hospitalization| O| R |