MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-29 for PARABATH manufactured by Hygienics Industries, Inc..
[17514]
During therapy regimen, right hand was dipped in paraffin and wrapped for 15 minutes. The pt returned for therapy the next day with a dime-sized blister which appeared to be a burn on the right finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29613 |
| MDR Report Key | 29613 |
| Date Received | 1995-12-29 |
| Date of Report | 1995-12-26 |
| Date of Event | 1995-10-03 |
| Date Facility Aware | 1995-10-06 |
| Date Reported to FDA | 1995-12-28 |
| Date Reported to Mfgr | 1995-12-28 |
| Date Added to Maude | 1996-02-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PARABATH |
| Generic Name | PARAFFIN BATH |
| Product Code | IMC |
| Date Received | 1995-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30702 |
| Manufacturer | HYGIENICS INDUSTRIES, INC. |
| Manufacturer Address | 114 LEMONTON WAY RADNOR PA 19087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-29 |