FDA Adverse Event
Injury
Summary report: N
STRYKER DRILL GUARD - BUR GUARD
MDR report key: 1723081
·
Received June 8, 2010
Report
- Report Number
- MW5016290
- Event Type
- Injury
- Date Received
- June 8, 2010
- Date of Event
- May 12, 2010
- Report Date
- June 8, 2010
- Manufacturer
- STRYKER SURGICAL
- Product Code
- EJL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STRYKER TPS HALL DRILL W/GUARD IN PLACE OVERHEATED, MELTED AND BURNED PT LIP. DATES OF USE: (B) (6) 1999 - (B) (6) 2010. REASON FOR USE: PROTECT PT'S LIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER DRILL GUARD - BUR GUARD | DRILL GUARD | EJL | STRYKER SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Disability |