MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-26 for KNEAL KNEECRUSIER SP - BLUE manufactured by Vergon.
[2071423]
Front bottom crossmember suddenly failed (right side of front "axle" snapped off completely going slowly over flat ground) causing me to fall shortly after ankle surgery. Product was purchased new and was used lightly for approx 2 months total over course of ownership. Because, the item was a few months out of warranty, this company would offer no remedy for repair or replacement off the frame (paid or unpaid). Company didn't even want to examine the unit to make sure it wouldn't happen to others. Incident date: (b)(6) 2011 this is an estimate. Injury, first aid received by non-medical professional. Purchase date: (b)(6) 2009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021180 |
| MDR Report Key | 2147448 |
| Date Received | 2011-06-26 |
| Date of Report | 2011-06-26 |
| Date Added to Maude | 2011-07-06 |
| 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 |
| Health Professional | 0 |
| 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 | KNEAL KNEECRUSIER SP - BLUE |
| Generic Name | KNEE WALKER |
| Product Code | ION |
| Date Received | 2011-06-26 |
| Model Number | KNEAL KNEECRUSIER SP - BLUE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERGON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-26 |