FDA Adverse Event
Injury
Summary report: N
LECTROVAC II 6-INCH
MDR report key: 813010
·
Received February 2, 2007
Report
- Report Number
- 1717344-2007-00033
- Event Type
- Injury
- Date Received
- February 2, 2007
- Date of Event
- November 17, 2006
- Report Date
- January 5, 2007
- Manufacturer
- VALLEYLAB, QA
- Product Code
- GEI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FILE WILL BE UPDATED AS SOON AS ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
PROCEDURE: T + A/ TONSILECTOMY. REPORTEDLY, THE PT ENDED UP WITH A BURN ON THEIR TONGUE THAT SHOWED UP THE DAY AFTER SURGERY. PT HAD TO BE ADMITTED FOR FLUIDS BECAUSE SHE WOULDN'T EAT. THE BURN DID NOT SHOW UP UNTIL AFTER THE SURGERY WAS DONE. THE PT PROGRESS REPORT STATES THAT THE PT IS WELL AND IN GOOD HEALTH CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LECTROVAC II 6-INCH | ELECTROSURGICAL ACCESSORY | GEI | VALLEYLAB, QA | * | 98345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |