FDA Adverse Event
Other
Summary report: N
SPORTX
MDR report key: 417573
·
Received September 16, 2002
Report
- Report Number
- 2126518-2002-00001
- Event Type
- Other
- Date Received
- September 16, 2002
- Report Date
- September 16, 2002
- Manufacturer
- REHABILICARE, INC.
- Product Code
- GZJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT RECEIVED SKIN IRRITATION, "BURN", UNDER ELECTRODE. WHICH DEVELOPED BLISTERS ASND SCARRED. PT SEEN BY DR WHO STATED IT WAS A "DEEP TISSUE BURN" AND GAVE PT INJECTIONS FOR SCARRING. SENT PT ANOTHER TYPE OF ELECTRODE TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPORTX | TENS | GZJ | REHABILICARE, INC. | 7700S | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |