FDA Adverse Event
Malfunction
Summary report: N
HI PWR DISPOSBL GRNDING PAD
MDR report key: 2123597
·
Received June 10, 2011
Report
- Report Number
- 1717344-2011-00448
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- April 6, 2011
- Report Date
- June 2, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
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 THAT WHEN THEY OPENED THE PAD PRIOR TO USE, THEY NOTICED DISCOLORATION ON THE GEL. THE PAD 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 | PATIENT RETURN ELECTRODE | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |