FDA Adverse Event
Malfunction
Summary report: N
BLADE ELECTRODE
MDR report key: 32728
·
Received February 10, 1996
Report
- Report Number
- 32728
- Event Type
- Malfunction
- Date Received
- February 10, 1996
- Report Date
- February 6, 1996
- Manufacturer
- EDWARD WEEK, INC.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LIP BURN AT JUNCTION OF PENCIL AND ELECTRODE WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLADE ELECTRODE | BLADE ELECTRODE | GEI | EDWARD WEEK, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |