MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-23 for ANODYNE THERAPY PROFESSIONAL SYSTEM 480 manufactured by Anodyne Therapy Services.
[18814215]
A pt experienced a quarter -sized, first to send degree burn on her right calf during therapy on that extremity with an andoyne infrared light therapy device. Reason for use: to increase circulation of the right lower extremity. The pt reported that her primary care physician diagnosed the quarter-sized red mark on her right calf as a 1st to 2nd degree burn, and that a topical ointment was prescribed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031075 |
| MDR Report Key | 3252332 |
| Date Received | 2013-07-23 |
| Date of Report | 2013-07-23 |
| Date of Event | 2013-07-15 |
| Date Added to Maude | 2013-07-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | ANODYNE THERAPY PROFESSIONAL SYSTEM |
| Generic Name | ANDOYNE INFRARED LIGHT THERAPY DEVICE |
| Product Code | ILY |
| Date Received | 2013-07-23 |
| Returned To Mfg | 2013-07-23 |
| Model Number | 480 |
| Lot Number | CE#04-155555 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANODYNE THERAPY SERVICES |
| Manufacturer Address | 141 MCCORMICK DR. TAMPA FL 33626 US 33626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-23 |