FDA Adverse Event
Malfunction
Summary report: N
HI PWR DISPOSBL GRNDING PAD
MDR report key: 2113028
·
Received May 25, 2011
Report
- Report Number
- 1717344-2011-00397
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 5, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED IT WAS NOTICED THE PREPARED PAD'S GEL COLOR LOOKED ABNORMAL. IT WAS NOT USED. INITIAL EVALUATION OF THE RETURNED SAMPLE FOUND THE FOIL WAS DEGRADED AND THE PAD SHOWED NO RESISTANCE.
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) | 171702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |