FDA Adverse Event
Summary report: N
DEROYAL BLADE
MDR report key: 2931584
·
Received January 21, 2013
Report
- Report Number
- 2931584
- Date Received
- January 21, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 21, 2013
- Manufacturer
- DEROYAL
- Product Code
- GES
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ABOUT 5 MONTHS AGO - BLADE BROKE WHEN REMOVED FROM ITS HANDLE. THIS WAS THE 2ND TIME THIS HAPPENED AND ACCORDING TO STAFF IS A FREQUENT OCCURRENCE.ABOUT 2 MONTHS AGO - KNIFE BLADE BROKE WHILE BEING REMOVED FROM THE HANDLE.ABOUT 2 WEEKS AGO - A #11 BLADE BROKE OFF INSIDE OF PT'S OPERATIVE KNEE. THE DOCTOR RECOVERED ALL PIECES DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28605 | DEROYAL BLADE | BLADE, SCALPEL | GES | DEROYAL | * | * | |
| 28606 | DEROYAL BLADE | BLADE, SCALPEL | GES | DEROYAL | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |