FDA Adverse Event
Malfunction
Summary report: N
ALLEGIANCE
MDR report key: 382212
·
Received March 11, 2002
Report
- Report Number
- 1030322-2002-00002
- Event Type
- Malfunction
- Date Received
- March 11, 2002
- Date of Event
- February 7, 2002
- Report Date
- February 18, 2002
- Manufacturer
- AARON MEDICAL INDUSTRIES
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DEVICE WAS BLAZING IN THE OPERATIVE FIELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGIANCE | CAUTERY | GEI | AARON MEDICAL INDUSTRIES | AA05 | 0601-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |