MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-06 for * 112 manufactured by Ille Div. Of Market Forge (ferno Washington, Inc.).
[235300]
Pt was instructed to place hand in paraftin bath by therapist. Pt c/o bath being "hot". When therapist checked temp it was 155 degrees. Pt received 1st degree burn to fingers. Therapist found switch had been changed to "start" instead of "operate". No info on device re: safe/therapeutic temp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021013 |
| MDR Report Key | 315082 |
| Date Received | 2001-02-06 |
| Date of Report | 2001-02-05 |
| Date of Event | 2001-01-17 |
| Date Added to Maude | 2001-02-09 |
| 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 | RISK MANAGER |
| 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 | * |
| Generic Name | PARAFTIN CONSTANT TEMP BATH |
| Product Code | IMC |
| Date Received | 2001-02-06 |
| Model Number | 112 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 304702 |
| Manufacturer | ILLE DIV. OF MARKET FORGE (FERNO WASHINGTON, INC.) |
| Manufacturer Address | * WILLIAMSPORT PA 17701 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-02-06 |