MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-02-01 for SKIL-CARE manufactured by Skil-care Corp.
[2370943]
Velcro strap became loose and pt fell and fractured her right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2392881 |
| MDR Report Key | 2392881 |
| Report Source | 99 |
| Date Received | 2007-02-01 |
| Date of Report | 2007-01-02 |
| Date of Event | 2006-12-26 |
| Date Facility Aware | 2006-12-28 |
| Report Date | 2007-01-02 |
| Date Added to Maude | 2012-01-03 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIL-CARE |
| Generic Name | BOLSTER |
| Product Code | KNO |
| Date Received | 2007-02-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKIL-CARE CORP |
| Manufacturer Address | 29 WELLS AVE NY 10701 US 10701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-01 |