MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-21 for CAST DRYER CM * manufactured by Jt Posey Co..
[22075446]
Pt developed minor burn-blister from bedwarmer nozzle. Biomed evaluation: device does not have an over temp cut-off mechanism. No previous history of device failure. Bedwarmer removed from svc not to be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 270607 |
| MDR Report Key | 270607 |
| Date Received | 2000-03-21 |
| Date of Report | 2000-03-20 |
| Date of Event | 2000-03-01 |
| Date Facility Aware | 2000-03-14 |
| Report Date | 2000-03-20 |
| Date Added to Maude | 2000-03-27 |
| 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 |
| 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 | CAST DRYER |
| Generic Name | BEDWARMER |
| Product Code | LGG |
| Date Received | 2000-03-21 |
| Model Number | CM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 40 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 261971 |
| Manufacturer | JT POSEY CO. |
| Manufacturer Address | 801 N. LAKE AVE. PASADENA CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-03-21 |