FDA Adverse Event
Other
Summary report: N
THERMOGARD DISPERSIVE ELECTRODE
MDR report key: 1632754
·
Received February 5, 2010
Report
- Report Number
- 1320894-2010-00011
- Event Type
- Other
- Date Received
- February 5, 2010
- Date of Event
- January 28, 2010
- Report Date
- February 5, 2010
- Manufacturer
- CONMED CORPORATION
- Product Code
- DRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. WHEN THE QUALITY ENGINEER COMPLETES THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT "DURING LEEP PROCEDURE, PT FELT SHOCKING IN LEG, BUT PROCEDURE CONTINUED (THEY CHECKED THE PAD, WIRES, ESU AT THIS TIME AND ALL APPEARED OK), PT FELT "SHOCK" IN LEG AGAIN, WHEN THE PAD WAS REMOVED A SMALL BURN WAS NOTICED AROUND ONE OF THE EDGES CLOSET TO THE CONNECTOR. PROCEDURED STOPPED FOR APPX. 5 MINUTES, WHILE A NEW PAD WAS POSITIONED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOGARD DISPERSIVE ELECTRODE | DISPERSIVE ELECTRODE | DRX | CONMED CORPORATION | NA | 0907131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | (B)(4) |