MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for CAREX FGA99500 0000 manufactured by .
[130790653]
In (b)(6) 2017, the user was severely injured when the crutches collapsed and bent while he was descending a staircase. Manufacturer of device involved with event could not be determined due to lack of serial/lot number information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00063 |
| MDR Report Key | 8176803 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-18 |
| Date Facility Aware | 2018-11-13 |
| Report Date | 2018-12-18 |
| Date Reported to FDA | 2018-12-18 |
| Date Added to Maude | 2018-12-18 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | CAREX |
| Generic Name | FOLDING CRUTCHES |
| Product Code | IPR |
| Date Received | 2018-12-18 |
| Model Number | FGA99500 0000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-18 |