MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for DRIVE YOUTH CRUTCHES 10431-8 manufactured by .
[6633925]
(b)(6) year old patient with knee injury, given crutches for non-weight bearing right knee. One crutch buckled when the patient began to use the crutches, causing the patient to fall and hit her head. The plastic piece that locks the length of the crutch leg does not lock - defective - pulls off of crutch. Patient did not suffer additional injury. Patient given second set of crutches. Defective pair of crutches sequestered to be returned to manufacturer. Eight year old patient suffered right knee injury in a bicycle crash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044857 |
| MDR Report Key | 4949662 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-23 |
| Date of Event | 2015-07-17 |
| Date Added to Maude | 2015-07-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE YOUTH CRUTCHES |
| Generic Name | DRIVE YOUTH CRUTCHES |
| Product Code | INP |
| Date Received | 2015-07-23 |
| Model Number | 10431-8 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-23 |