FDA Adverse Event
Other
Summary report: N
ELECTRODE PAD, SPLIT
MDR report key: 1190864
·
Received October 6, 2008
Report
- Report Number
- 1643264-2008-00018
- Event Type
- Other
- Date Received
- October 6, 2008
- Date of Event
- August 28, 2008
- Report Date
- September 5, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- ODR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A VALLEY LAB SPLIT PAD WAS PLACED ON THE THIGH OF THE OPERATIVE SIDE OF THE PATIENT. AFTER THE CASE, WHEN PAD WAS REMOVED THERE WAS A 1" ROUND BURN ON THE THIGH. NO OTHER INFORMATION IS AVAILABLE FOR THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTRODE PAD, SPLIT | GROUND PAD | ODR | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7209687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |