FDA Adverse Event
Malfunction
Summary report: N
VAGINA MESH FOR PROLAPSE
MDR report key: 2220441
·
Received August 17, 2011
Report
- Report Number
- MW5021804
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- November 7, 2007
- Report Date
- August 17, 2011
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I WENT TO (B)(6) HOSPITAL FOR VAGINAL HYSTERECTOMY DUE TO STAGE 2 PROLAPSE. I HAVE BEEN HAVING A LOT OF FEMALE PROBLEMS SINCE THEN. THE LACK OF SEXUAL ACTIVITY AND CONSTANT PAIN IN THE LOWER STOMACH AND FEMALE AREA. WAS WONDERING IF MAYBE I COULD HAVE BEEN EFFECTED BY THE MESH THAT THEY USED TO TREAT ME IN THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAGINA MESH FOR PROLAPSE | VAGINAL MESH USED FOR HYSTERECTOMY | FTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |