FDA Adverse Event
Malfunction
Summary report: N
BURN SKIN STAPLER FROM STERILE BARCODE BURN PACK
MDR report key: 2679173
·
Received July 29, 2012
Report
- Report Number
- 2679173
- Event Type
- Malfunction
- Date Received
- July 29, 2012
- Date of Event
- May 14, 2012
- Report Date
- July 29, 2012
- Manufacturer
- SRI SURGICAL
- Product Code
- FSM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SKIN STAPLERS STOPPED WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BURN SKIN STAPLER FROM STERILE BARCODE BURN PACK | STAPLER IN SURGICAL TRAY | FSM | SRI SURGICAL | * | 084894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |