FDA Adverse Event
Malfunction
Summary report: N
HI PWR DISPOSBL GRNDING PAD
MDR report key: 2121478
·
Received May 6, 2011
Report
- Report Number
- 1717344-2011-00351
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- March 18, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED 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 PRIOR TO THE PROCEDURE, EXAMINATION FOUND, THE PAD WAS DISCOLORED AND DARKENED. IT WAS NOT USED FOR THE PROCEDURE. 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) | 188121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |