MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-01-09 for FERNO STAINLESS STEEL PARAFFIN BATH 940 manufactured by Ferno-washington, Inc..
[298917]
Customer claims unit overheats. Adjusting thermostat does not lower the temperature. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523574-2003-00004 |
| MDR Report Key | 437474 |
| Report Source | 06 |
| Date Received | 2003-01-09 |
| Date of Report | 2002-11-20 |
| Date Mfgr Received | 2002-11-20 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2003-01-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RICHARD NICOL |
| Manufacturer Street | 70 WEIL WAY |
| Manufacturer City | WILMINGTON OH 45177 |
| Manufacturer Country | US |
| Manufacturer Postal | 45177 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FERNO STAINLESS STEEL PARAFFIN BATH |
| Generic Name | AMBULANCE COT |
| Product Code | IMC |
| Date Received | 2003-01-09 |
| Model Number | 940 |
| Catalog Number | 940 |
| Lot Number | M-225050 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 426410 |
| Manufacturer | FERNO-WASHINGTON, INC. |
| Manufacturer Address | 70 WEIL WAY WILMINGTON OH 45177 US |
| Baseline Brand Name | FERNO PARAFFIN BATH |
| Baseline Generic Name | PARAFFIN BATH |
| Baseline Model No | 940 |
| Baseline Catalog No | 930 |
| Baseline Device Family | FERNO STAINLESS STEEL PARAFFIN BATH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-01-09 |