FDA Adverse Event
Other
Summary report: N
THERMOGARD DISPERSIVE ELECTRODE
MDR report key: 925273
·
Received October 10, 2007
Report
- Report Number
- 1320208-2007-00136
- Event Type
- Other
- Date Received
- October 10, 2007
- Date of Event
- July 1, 2007
- Report Date
- October 10, 2007
- Manufacturer
- CONMED CORP.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE GROUND PAD WAS RETURNED. THE QUALITY ENGINEER WILL CONDUCT A REVIEW OF THE DEVICE PRODUCTION RECORDS, AND DO A THOROUGH EXAMINATION OF THE RETURNED PRODUCT. UPON RECEIPT OF THE QUALITY ENGINEER'S INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL. PLEASE NOTE: DATE GIVEN TO CONMED CORPORATION WAS 2007, NO SPECIFIC DATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT "FOLLOWING A SURGICAL PROCEDURE IT WAS NOTED THAT THE PATIENT HAD SUSTAINED A 3CM 3RD DEGREE BURN ON THE CALF OF THE LEG AT THE PAD APPLICATION SITE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOGARD DISPERSIVE ELECTRODE | DISPERSIVE ELECTRODE | GEI | CONMED CORP. | NA | 0702131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other | ESU USED: MDT BOVIE 400CT |