MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-14 for DISPOSABLE REPO SHEET SOLOREPO SHEET 36871003 manufactured by Liko Ab.
[19901694]
Facility staff state that when they were lifting a pt up to place an x-ray plate behind the pt, that the solo repositioning sheet tore and the pt fell back on to the bed 1-2 inches. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006252983-2008-00012 |
| MDR Report Key | 1032553 |
| Date Received | 2008-04-14 |
| Date of Report | 2008-03-17 |
| Date of Event | 2008-03-15 |
| Date Facility Aware | 2008-03-17 |
| Report Date | 2008-04-14 |
| Date Reported to FDA | 2008-04-14 |
| Date Reported to Mfgr | 2008-03-17 |
| Date Added to Maude | 2008-04-24 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE REPO SHEET |
| Generic Name | BEDDING, DISPOSABLE, MEDICAL |
| Product Code | KME |
| Date Received | 2008-04-14 |
| Model Number | SOLOREPO SHEET |
| Catalog Number | 36871003 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 999656 |
| Manufacturer | LIKO AB |
| Manufacturer Address | NEDRE VAGEN 100 LULEA SW 975 92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-14 |