MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-01 for PARABATH 5/N944691 manufactured by Hygenic Corp.
[22094779]
Electric paraffin bath thermostat not working correctly causing temp to be too hot. Dates of use: (b)(6) 1998 - (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019244 |
| MDR Report Key | 1980053 |
| Date Received | 2011-02-01 |
| Date of Report | 2011-02-01 |
| Date of Event | 2011-01-22 |
| Date Added to Maude | 2011-02-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARABATH |
| Generic Name | PARABATH |
| Product Code | IMC |
| Date Received | 2011-02-01 |
| Model Number | 5/N944691 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGENIC CORP |
| Manufacturer Address | AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-01 |