FDA Adverse Event
Injury
Summary report: N
CAUTERY GROUND PAD
MDR report key: 13586
·
Received May 25, 1994
Report
- Report Number
- MW1002253
- Event Type
- Injury
- Date Received
- May 25, 1994
- Date of Event
- March 23, 1994
- Report Date
- May 9, 1994
- Manufacturer
- CONMED CORP.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DR BEGAN CAUTERIES AROUND STERNAL WIRES AND THE REM ALARM SOUNDED AND INTERRUPTED CAUTERY OPERATION. TWO ESU'S WERE BEING USED SIMULTANEOUSLY. ESU'S PAD WAS CHANGED AS WELL AS CAUTERY PENCILS. REM ALARM STOPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAUTERY GROUND PAD | GEI | CONMED CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |