MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for PARAFFIN BATH FOR ARTHRITIS THERAPY OF HANDS AND FEET manufactured by Unk.
[144181922]
This is paraffin bath for dipping hands and feet for arthritis therapy. There is no buffer inside between metal that heats paraffin and area you are to put hands and feet. (small grid you throw in bottom but provides no help for feet). As a result, feet especially touch burning hot side metal. There is no way around this. I did not sustain serious burn but anyone using device could easily. (b)(6). Purchase date: (b)(6) 2019. The product was not damaged before the incident. The product was not modified before the incident. I have contacted for a refund. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086371 |
| MDR Report Key | 8577984 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-14 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARAFFIN BATH FOR ARTHRITIS THERAPY OF HANDS AND FEET |
| Generic Name | PARAFFIN WAX BATH |
| Product Code | IMC |
| Date Received | 2019-05-02 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |