MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for CAREX FGA50500 0000 A505-00 manufactured by Aid-pro Combridge.
[99131965]
End-user was walking in restaurant parking lot with cane when the device bent and she fell on her left side. The user broke her hip and required surgery. User is now in rehab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00002 |
| MDR Report Key | 7244865 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-11-30 |
| Date of Event | 2017-12-22 |
| Date Facility Aware | 2018-11-26 |
| Report Date | 2018-11-30 |
| Date Reported to FDA | 2018-11-30 |
| Date Reported to Mfgr | 2018-11-30 |
| Date Added to Maude | 2018-02-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | SOFT GRIP CANE |
| Product Code | IPS |
| Date Received | 2018-02-06 |
| Model Number | FGA50500 0000 |
| Catalog Number | A505-00 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AID-PRO COMBRIDGE |
| Manufacturer Address | UNIT 1, NO. 66, YU LONG 3 RD D ZHONG SHAN CITY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-02-06 |