MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-25 for KINEDYNE FE 500 SERIES FE200595 manufactured by Kinedyne Corp..
[24574]
Resident was being transported to a dr appointment by the facility van. Resident was seat belted into a w/c and w/c was secured to the van floor. The van came to a stop at an intersection and resident fell forward out of w/c and hit her face on door handle. Resident had 4 inches of stitches on face. Possible fracture of l femoral neck. Possible fracture of proximal tib and fib.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 44826 |
| MDR Report Key | 44826 |
| Date Received | 1996-09-25 |
| Date of Report | 1996-09-19 |
| Date of Event | 1996-09-16 |
| Date Facility Aware | 1996-09-16 |
| Report Date | 1996-09-19 |
| Date Added to Maude | 1996-10-29 |
| 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 | KINEDYNE |
| Generic Name | WHEELCHAIR SECUREMENT AND SAFETY BELT |
| Product Code | IQB |
| Date Received | 1996-09-25 |
| Model Number | FE 500 SERIES |
| Catalog Number | FE200595 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 30 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 45735 |
| Manufacturer | KINEDYNE CORP. |
| Manufacturer Address | 3701 GREENWAY CIRCLE LAWRENCE KS 660465442 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 1996-09-25 |