MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-04 for W/C-IV POLE-ANTI TIPPER-SOFT RESTR BELT manufactured by .
[1197038]
Resident with late stage dementia unable to stand without assist has soft lap belt ordered for positioning. Strap for soft lap belt is to be attached behind w/c to rear anti-tip bar which attaches to w/c frame. Rear anti-tip bar was attached to iv pole tube tubing which does not secure rear anti-tip causing strap to come if allowing resident to slide out of chair. Fall resulted in hip fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1399566 |
| MDR Report Key | 1399566 |
| Report Source | 99 |
| Date Received | 2009-06-04 |
| Date of Report | 2009-06-04 |
| Date of Event | 2009-05-16 |
| Date Facility Aware | 2009-05-16 |
| Report Date | 2009-06-04 |
| Date Reported to FDA | 2009-06-04 |
| Date Added to Maude | 2009-06-15 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | W/C-IV POLE-ANTI TIPPER-SOFT RESTR BELT |
| Product Code | KID |
| Date Received | 2009-06-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-06-04 |