MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-07-18 for THERABATH TB II NA manufactured by Wr Medical Electronics Co..
[17768788]
Pt may have damage to small cutaneous fibers in their feet brought on by paraffin treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2118418-2003-00001 |
| MDR Report Key | 497999 |
| Report Source | 00 |
| Date Received | 2003-07-18 |
| Date of Report | 2003-07-18 |
| Date of Event | 2001-02-16 |
| Date Mfgr Received | 2003-07-03 |
| Date Added to Maude | 2003-12-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JEANNE ANDERSON |
| Manufacturer Street | 123 NORTH SECOND STREET |
| Manufacturer City | STILLWATER MN 55082 |
| Manufacturer Country | US |
| Manufacturer Postal | 55082 |
| Manufacturer Phone | 6514308457 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABATH |
| Generic Name | PARAFFIN HEAT THERAPY BATH |
| Product Code | IMC |
| Date Received | 2003-07-18 |
| Model Number | TB II |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 486746 |
| Manufacturer | WR MEDICAL ELECTRONICS CO. |
| Manufacturer Address | 123 NORTH SECOND STREET STILLWATER MN 55082 US |
| Baseline Brand Name | THERABATH |
| Baseline Generic Name | PARAFFIN HEAT THERAPY BATH |
| Baseline Model No | TB II |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-18 |