FDA Adverse Event
Malfunction
Summary report: N
ELECTRODES
MDR report key: 17535712
·
Received August 12, 2023
Report
- Report Number
- MW5142607
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- April 19, 2017
- Manufacturer
- MEDEQUIP INC.
- Product Code
- GXY
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
(B)(6) 2016 END USER CALLED AND STATED THE (ELECTRODE) PAD IS GIVING HER A RASH ON HER LEFT SHOULDER/ARM. LOOKS LIKE THE MEASLES. SHE IS ALLERGIC TO LATEX. RASH IS ONLY WHERE SHE PLACED THE ELECTRODES. NOTE: END USER WAS USING THE ELECTRODES WITH A COMPASS HEALTH BRANDS DEVICE (ACRL-3000). WE ORIGINALLY ASSUMED THEY WERE COMPASS HEALTH BRANDS ELECTRODES, BUT UPON EVALUATION OF THE RETURNED DEVICES, DETERMINED THAT THEY WERE: NI. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1073275 | ELECTRODES | ELECTRODE, CUTANEOUS | GXY | MEDEQUIP INC. | P850090 | AM000020122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |