FDA Adverse Event
Injury
Summary report: N
MICROAIRE
MDR report key: 599336
·
Received May 2, 2005
Report
- Report Number
- 2020601-2005-00002
- Event Type
- Injury
- Date Received
- May 2, 2005
- Date of Event
- March 29, 2005
- Report Date
- May 2, 2005
- Manufacturer
- MICROAIRE SURGICAL INSTRUMENTS, LLC
- Product Code
- HTW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INSTRUMENT HAD BECOME HOT WHILE IN USE. AND HAD ALLEGEDLY BURNED THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROAIRE | HIGH SPEED DRILL | HTW | MICROAIRE SURGICAL INSTRUMENTS, LLC | 2910-200 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Other |