MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-06 for OASIS ELITE * EL141 manufactured by Trulife.
[295450]
This pt underwent a multi-level lumbar spine fusion and was prone for approximately 8 hours on a jackson table. Their face was padded with a gel ring. At the end of the procedure it was noted that there was an area of indentation on the pt's forehead. The skin broke down in the area, and it is undetermined what the ultimate cosmetic result will be.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 487905 |
| MDR Report Key | 487905 |
| Date Received | 2003-10-06 |
| Date of Report | 2003-06-01 |
| Date of Event | 2003-04-01 |
| Date Added to Maude | 2003-10-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | OASIS ELITE |
| Generic Name | PRONE HEADREST |
| Product Code | KME |
| Date Received | 2003-10-06 |
| Model Number | * |
| Catalog Number | EL141 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 476764 |
| Manufacturer | TRULIFE |
| Manufacturer Address | PO BOX 89 JACKSON MI 49204 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-06 |