FDA Adverse Event
Malfunction
Summary report: N
BATTERY OPERATE CAUTERY
MDR report key: 528417
·
Received February 26, 2004
Report
- Report Number
- 528417
- Event Type
- Malfunction
- Date Received
- February 26, 2004
- Date of Event
- January 2, 2004
- Report Date
- January 13, 2004
- Manufacturer
- MEDICHOIC
- Product Code
- HQP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
BATTERY OPERATED CAUTERY USED. IGNITED SPONGE DURING SURGERY AND BURNED UPPER LIP, RIGHT LOWER LIP, ROOF OF MOUTH, AND TONGUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BATTERY OPERATE CAUTERY | * | HQP | MEDICHOIC | 0011055401 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |