FDA Adverse Event
Malfunction
Summary report: N
DISP PNCL W/HLSTR BULKPAK
MDR report key: 1690826
·
Received May 10, 2010
Report
- Report Number
- 1717344-2010-00331
- Event Type
- Malfunction
- Date Received
- May 10, 2010
- Date of Event
- April 14, 2010
- Report Date
- April 15, 2010
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE PATIENT WAS BURNED WITH THE CAUTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISP PNCL W/HLSTR BULKPAK | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | 164663 OR 166353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |