FDA Adverse Event
Other
Summary report: N
STIMCARE ELECTRODES
MDR report key: 436717
·
Received January 8, 2003
Report
- Report Number
- 2126518-2002-00002
- Event Type
- Other
- Date Received
- January 8, 2003
- Report Date
- January 8, 2003
- Manufacturer
- REHABILICARE, INC.
- Product Code
- GZJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT REC'D SMALL (REDNESS) BURNS AROUND PERIMETER OF ELECTRODE DURING ELECTROTHERAPY TREATMENT AT CLINIC USING A CHATTANOOGA INTERFERENTIAL DEVICE. PT WAS SEEN BY DOCTOR WHO PRESCRIBED POLYSPORIN OINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STIMCARE ELECTRODES | ELECTRODES TENS | GZJ | REHABILICARE, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |