MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-20 for THERATOUCH 4.7 * manufactured by Rich-mar, Inc..
[2236546]
Burn blister to patient caused by electrical stimulation device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2274374 |
| MDR Report Key | 2274374 |
| Date Received | 2011-09-20 |
| Date of Report | 2011-09-20 |
| Date of Event | 2011-05-27 |
| Report Date | 2011-09-20 |
| Date Reported to FDA | 2011-09-20 |
| Date Added to Maude | 2011-10-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATOUCH 4.7 |
| Generic Name | INTERFERENTIAL CURRENT THERAPY |
| Product Code | LIH |
| Date Received | 2011-09-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Age | 6 YRS |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICH-MAR, INC. |
| Manufacturer Address | 4120 SOUTH CREEK ROAD CHATTANOOGA TN 37406 US 37406 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-20 |