FDA Adverse Event
Injury
Summary report: N
MESH
MDR report key: 2801776
·
Received October 19, 2012
Report
- Report Number
- MW5027264
- Event Type
- Injury
- Date Received
- October 19, 2012
- Date of Event
- May 10, 2012
- Report Date
- October 19, 2012
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HAD AN INGUINAL HERNIA REPAIR IN (B)(6) 2012 WITH A MESH. HAS BEEN IN CHRONIC PAIN AND LIMITED ACTIVITY SINCE THEN. HE CANNOT LIFT NOR WORK. THE RIGHT SIDE OF HIS ABDOMEN FEELS LUMPY. HE IS SCHEDULED FOR SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MESH | FTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention |