FDA Adverse Event
Malfunction
Summary report: N
HI PWR DISPOSBL GRNDING PAD
MDR report key: 2121498
·
Received May 6, 2011
Report
- Report Number
- 1717344-2011-00354
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 27, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING PREP FOR THE SURGERY, IT WAS NOTICED THE PAD WAS DISCOLORED. IT WAS NOT USED FOR THE PT. INITIAL EVAL OF THE INCIDENT SAMPLE FOUND IT DID NOT HAVE CONTINUITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HI PWR DISPOSBL GRNDING PAD | RF ABLATION GROUNDING PAD | GEI | COVIDIEN LP (VALLEYLAB) | 181484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |