MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-25 for CHATTANOOGA CPS400 manufactured by Chattanooga Group Inc.
[21493655]
Pt came into therapy on (b)(6) 2014 and stated that he had been burned on (b)(6) 2014 on his right leg after e-stim usage. Upon examination of the leg, a small circular wound with a white center was found by his knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037499 |
| MDR Report Key | 3966592 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-01 |
| Date Added to Maude | 2014-07-31 |
| 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 | CHATTANOOGA CPS400 |
| Generic Name | CHATTANOOGA CPS400 |
| Product Code | IMG |
| Date Received | 2014-07-25 |
| Model Number | CPS400 |
| ID Number | 402934884 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-25 |