MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-17 for ALPHA STIM 100 MICROCURRENT AND CRANIAL ELECTROTHERAPY manufactured by Electromedical Products Int'l.
[21412903]
During a treatment, pt was burned on both ears by the device that was used. Pt was using the device as prescribed and instructed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025466 |
| MDR Report Key | 2585144 |
| Date Received | 2012-05-17 |
| Date of Report | 2012-05-17 |
| Date Added to Maude | 2012-05-24 |
| 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 | 3 |
| 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 |
| Brand Name | ALPHA STIM 100 MICROCURRENT AND CRANIAL ELECTROTHERAPY |
| Generic Name | ALPHA STIM |
| Product Code | JXK |
| Date Received | 2012-05-17 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELECTROMEDICAL PRODUCTS INT'L |
| Manufacturer Address | 2201 GARRETT MORRIS PKWY MINERAL WELLS TX 76067 US 76067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-17 |