MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for FOREARM CRUTCHES LOT # SKD manufactured by Kx Medical.
[107743004]
Forearm crutches purchased from kx medical 2014 snapped in half while walking. Crutch was replaced by company in 2016. Exact same crutch failure happened again in 2018. Aluminium just snapped in half causing me to fall. I am disabled (1991) and require crutches for ambulation. Never had failure with any other brand of crutch. This is repeat failure of exact same problem with exact same equipment and same manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077062 |
| MDR Report Key | 7494210 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-05-02 |
| Date Added to Maude | 2018-05-08 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | FOREARM CRUTCHES |
| Generic Name | FOREARM CRUTCHES |
| Product Code | IPR |
| Date Received | 2018-05-07 |
| Model Number | LOT # SKD |
| Lot Number | SKD |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KX MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-07 |