MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-03 for ULTIMATE SPA 1440030601 NA manufactured by Styling Technologies.
[277599]
Rptr reported that the 6lb block of wax melted in the machine and leaked out onto their oriental rug and all over the furniture. Rptr worried that their pts could have been burned from the hot wax. The paraffin is supposed to melt at 150 degrees which is very hot. Machine had a hole in it. The rptr returned machine to store, they discovered that it had a hole in it. They were given a new machine to replace the damaged one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003292 |
| MDR Report Key | 396456 |
| Date Received | 2002-04-03 |
| Date of Report | 2002-04-03 |
| Date of Event | 2002-03-24 |
| Date Added to Maude | 2002-05-30 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTIMATE SPA |
| Generic Name | PARAFFIN THERAPY MACHINE |
| Product Code | IMC |
| Date Received | 2002-04-03 |
| Model Number | 1440030601 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 385484 |
| Manufacturer | STYLING TECHNOLOGIES |
| Manufacturer Address | 7400 E TIERRA BUENA LN SCOTTSDALE AZ 852601613 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-03 |