FDA Adverse Event
Malfunction
Summary report: N
SUCTION COAGULATOR
MDR report key: 1945179
·
Received December 9, 2010
Report
- Report Number
- 1945179
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- December 8, 2010
- Report Date
- December 9, 2010
- Manufacturer
- A & E MEDICAL
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON THE WAND OF THE DEVICE THERE IS UNKNOWN DARK GOLD COLORED DUST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUCTION COAGULATOR | SUCTION COAGULATOR | GEI | A & E MEDICAL | * | PACK LOT # 987873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |