MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-07 for THE AFTERMARKET GROUP manufactured by United Plastic Molders, Inc..
[54922003]
Safety device that holds the nut in place that connects brakes to wheelchair did not keep nut in place despite following manufacturer's installation instructions. Position of bolt allows torque from brakes to loosen nut beyond the positioning of the safety cap that covers the nut. Wheel fell off wheelchair causing fall with head injury. All of these same brakes are removed from other wheelchairs. Upon removal of these same brakes from other wheelchairs, the nut was loose behind each of the orange safety caps. It appears that the orange safety cap covers approximately 1/4 inch or less of the bolt and the torque from braking results in a loosened nut with that doesn't engage the 1/4 inch of protection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5952916 |
| MDR Report Key | 5952916 |
| Date Received | 2016-09-07 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-09-04 |
| Date Facility Aware | 2014-09-04 |
| Report Date | 2016-09-09 |
| Date Reported to FDA | 2016-09-09 |
| Date Reported to Mfgr | 2016-09-09 |
| Date Added to Maude | 2016-09-15 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THE AFTERMARKET GROUP |
| Generic Name | SECURE AUTOMATIC WHEEL LOCK KIT |
| Product Code | KNO |
| Date Received | 2016-09-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 30 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED PLASTIC MOLDERS, INC. |
| Manufacturer Address | JACKSON MS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2016-09-07 |