MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-14 for THERABATH TB5 * manufactured by Wr Medical Electronics Co..
[20242817]
Device was prescribed for thumb pain from arthritis. Device was purchased and did not generate sufficient heat to penetrate as it was supposed to. The unit was exchanged for another which also failed to generate sufficient heat. (a hot water soak from the tap was far superior). Although the mfr guarantees (lifetime) the product and event was reported within days, neither the retailer nor the mfr would refund the money or allow the return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010958 |
| MDR Report Key | 76213 |
| Date Received | 1997-03-14 |
| Date of Report | 1997-03-03 |
| Date of Event | 1996-11-01 |
| Date Added to Maude | 1997-03-18 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABATH |
| Generic Name | PARAFIN HEAT THERAPY SYSTEM |
| Product Code | IMC |
| Date Received | 1997-03-14 |
| Model Number | TB5 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 75958 |
| Manufacturer | WR MEDICAL ELECTRONICS CO. |
| Manufacturer Address | 123 NORTH SECOND ST STILLWATER MN 55082 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-14 |