FDA Adverse Event
Malfunction
Summary report: N
BOVIE PAD
MDR report key: 5017523
·
Received August 20, 2015
Report
- Report Number
- 5017523
- Event Type
- Malfunction
- Date Received
- August 20, 2015
- Date of Event
- June 16, 2015
- Report Date
- July 8, 2015
- Manufacturer
- BOVIE MEDICAL CORPORATION
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SEVERAL SMALL AREAS OF SUPERFICIAL SKIN LAYER PEELED OF WITH REMOVAL OF BOVIE PAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 551823 | BOVIE PAD | ELECTROSURGICAL, CUTTING & COAGULATIONS & ACCESSORIES | GEI | BOVIE MEDICAL CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |