FDA Adverse Event
Injury
Summary report: N
EDGE INSUL COATED NEEDLE
MDR report key: 1001956
·
Received February 20, 2008
Report
- Report Number
- 1717344-2008-00052
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- December 12, 2007
- Report Date
- January 24, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. THE SAMPLE HAS BEEN REQUESTED. IF THE SAMPLE IS REC'D OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE REPORTED STATED THAT DURING A TONSILLECTOMY PROCEDURE, THERE WAS AN ESTIMATED 2ND DEGREE BURN ABOUT 3MM ON THE LIP WHILE USING AN INSULATED DISPOSABLE PENCIL. TO TREAT THE BURN, THE SURGEON APPLIED 3 SUTURES AROUND THE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDGE INSUL COATED NEEDLE | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Other | PATIENT RETURN ELECTRODE - LOT # UNKNOWN| FORCEFX - ELECTROSURGICAL GENERATOR |