MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-09 for NC89255B manufactured by North Coast Medical, Inc..
[2440274]
After using norco electrodes, patient presented with residual small reddened burn area on forearm where pad had been placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024211 |
| MDR Report Key | 2450216 |
| Date Received | 2012-02-09 |
| Date of Event | 2012-01-12 |
| Date Added to Maude | 2012-02-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IONTOPHORESIS PADS |
| Product Code | EGJ |
| Date Received | 2012-02-09 |
| Model Number | NC89255B |
| ID Number | PART# 199334-001 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | 8100 CAMINO ARROYO GILROY CA 95020 US 95020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-09 |