FDA Adverse Event
Other
Summary report: N
MED ELECTRODE
MDR report key: 620900
·
Received July 1, 2005
Report
- Report Number
- 620900
- Event Type
- Other
- Date Received
- July 1, 2005
- Date of Event
- June 1, 2005
- Report Date
- July 1, 2005
- Manufacturer
- NORTH COAST MEDICAL, INC.
- Product Code
- EGJ
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
PATIENT CAME TO NEXT PT, PHYSICAL THERAPY, SESSION AND COMPLAINED OF A RASH AT THE SITE WHERE THE ELECTRODES HAD BEEN APPLIED DURING THE LAST VISIT. ADDITIONAL FOLLOW-UP REVEALS: FACILITY IS UNSURE IF IT IS THE ELECTRODE. THE STAFF STATED THAT OTHER PATIENTS COMPLAINED AFTER THEY USED THESE ELECTRODES AND SO THEY HAVE DISCONTINUED USING THEM. FACILITY DOES NOT BELIEVE IT WAS THE DRUG THAT CAUSED THE RASH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED ELECTRODE | ELECTRODE FOR IONTOPHORESIS | EGJ | NORTH COAST MEDICAL, INC. | * | 251343-003 RETURN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |