MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-11 for THERABATH PARAFFIN THERAPY BATH 50 - 60 HZ MODEL TB5 * manufactured by Wr Medical Electronics.
[2098330]
A patient was using the paraffin wax machine and developed a burn on distal tip of middle finger of right hand. The therapist checked the bottom on the inside of the machine and identified that there were several hot spots on the edges along the base (the wax was not too hot). The burn was a very small blister which did not require any treatment. Ten days after the occurrence, a follow up call elicited the information from the patient that all was fine and his finger was healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2163292 |
| MDR Report Key | 2163292 |
| Date Received | 2011-07-11 |
| Date of Report | 2011-07-11 |
| Date of Event | 2011-03-02 |
| Report Date | 2011-07-11 |
| Date Reported to FDA | 2011-07-11 |
| Date Added to Maude | 2011-07-15 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABATH PARAFFIN THERAPY BATH |
| Generic Name | PARAFFIN WAX BATH |
| Product Code | IMC |
| Date Received | 2011-07-11 |
| Model Number | 50 - 60 HZ MODEL TB5 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 15 + YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WR MEDICAL ELECTRONICS |
| Manufacturer Address | 123 N 2ND ST. STILLWATER MN 55082 US 55082 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-11 |