MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-20 for THERMAL CEILING MODEL OPNX11UL * manufactured by Aragona Medical, Inc..
[18610176]
Overbed heater remained in place longer than anticipated. When patient was transferred to the bed, she complained of pain in her back and being too hot. Patient sustained burn injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 930359 |
| MDR Report Key | 930359 |
| Date Received | 2007-09-20 |
| Date of Report | 2007-09-14 |
| Date of Event | 2007-09-12 |
| Report Date | 2007-09-14 |
| Date Reported to FDA | 2007-09-20 |
| Date Added to Maude | 2007-10-23 |
| 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 | THERMAL CEILING MODEL |
| Generic Name | WARMER, PATIENT |
| Product Code | IRQ |
| Date Received | 2007-09-20 |
| Model Number | OPNX11UL |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 14 YRS |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 902534 |
| Manufacturer | ARAGONA MEDICAL, INC. |
| Manufacturer Address | 184 RIVERVALE ROAD RIVER VALE NJ 07675 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2007-09-20 |