FDA Adverse Event
Malfunction
Summary report: N
PERSONNA
MDR report key: 1559175
·
Received December 3, 2009
Report
- Report Number
- 1559175
- Event Type
- Malfunction
- Date Received
- December 3, 2009
- Date of Event
- August 3, 2009
- Report Date
- December 3, 2009
- Manufacturer
- SOUTHMEDIC, INC.
- Product Code
- GES
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
BLADES CONTAIN A STICKY RESIDUE MAKING IT DIFFICULT TO OPEN THE PACKAGE AND AFFECTING THE BLADE.
Description of Event or Problem · 1
BLADES CONTAIN A STICKY RESIDUE MAKING IT DIFFICULT TO OPEN THE PACKAGE AND AFFECTING THE BLADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERSONNA | BLADE, SURGICAL | GES | SOUTHMEDIC, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |