MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-20 for KINEDYNE * manufactured by Sure-lok, Inc..
[246844]
Tiedown strap securing wheelchair in the transportation. Van failed when the spring in the latch on the strap popped out of position. The wheelchair overturned causing a bump to the right side of the resident's head and a skin tear to the right elbow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025466 |
| MDR Report Key | 402729 |
| Date Received | 2002-06-20 |
| Date of Report | 2002-06-20 |
| Date of Event | 2002-05-24 |
| Date Added to Maude | 2002-07-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KINEDYNE |
| Generic Name | TIEDOWN STRAP FOR WHEELCHAIR |
| Product Code | IQB |
| Date Received | 2002-06-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 391739 |
| Manufacturer | SURE-LOK, INC. |
| Manufacturer Address | 151 INDUSTRIAL PKWY BRANCHBURG NJ 088763451 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-20 |