FDA Adverse Event
Other
Summary report: N
ALLEGIANCE V. MUELLER
MDR report key: 145797
·
Received December 31, 1997
Report
- Report Number
- 145797
- Event Type
- Other
- Date Received
- December 31, 1997
- Date of Event
- September 12, 1997
- Report Date
- September 26, 1997
- Manufacturer
- ALLEGIANCE V. MUELLER
- Product Code
- GDG
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT RECEIVED MINOR SKIN BURN WHICH WAS BELIEVED DUE TO INSUFFICIENT INSULATION ON J HOOK USED DURING CHOLECYSTECTOMY. UNFORTUNATELY, THE J HOOK WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGIANCE V. MUELLER | J HOOK | GDG | ALLEGIANCE V. MUELLER | LA 1900 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other |