MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-10 for FOOT DETOX PAD manufactured by Wise Choice Health, Inc..
[837058]
Pt put the pad on the bottom of her foot and slept with it. Upon removal, she stated, it looked like varicose vein along with pain, cramping and bruise. Customer said that she never had varicose veins before. She was unable to provide any device id number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005899 |
| MDR Report Key | 1013938 |
| Date Received | 2008-03-10 |
| Date of Report | 2008-03-10 |
| Date Added to Maude | 2008-03-24 |
| 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 | 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 |
| Brand Name | FOOT DETOX PAD |
| Generic Name | NONE |
| Product Code | MLX |
| Date Received | 2008-03-10 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 983704 |
| Manufacturer | WISE CHOICE HEALTH, INC. |
| Manufacturer Address | 1800 S. ROBERTSON #398 LOS ANGELES CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-10 |