FDA Adverse Event
Malfunction
Summary report: N
DISP PNCL W/HLSTR BULKPAK
MDR report key: 1513987
·
Received October 12, 2009
Report
- Report Number
- 1717344-2009-00517
- Event Type
- Malfunction
- Date Received
- October 12, 2009
- Date of Event
- September 1, 2009
- Report Date
- September 14, 2009
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR 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 TO OUR DISTRIBUTOR THAT THE PENCIL HAD EXPOSED CAUTERY WIRES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISP PNCL W/HLSTR BULKPAK | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | 160011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |