FDA Adverse Event
Malfunction
Summary report: N
PREFIX PPF
MDR report key: 1037571
·
Received May 1, 2008
Report
- Report Number
- MW5006532
- Event Type
- Malfunction
- Date Received
- May 1, 2008
- Date of Event
- April 7, 2008
- Report Date
- May 1, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- FEC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
OBTURATOR WAS STICKING AND WOULD NOT ADVANCE MESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREFIX PPF | OBTURATOR | FEC | BOSTON SCIENTIFIC | M0068506000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |