MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for CAREX SMALL BASE DESIGNER QUAD CANE - BLACK FGA74100 0000 A741-00 manufactured by N/a.
[71679890]
The customer lost a tip on her quad cane and cannot find it anywhere; the tips kept falling off. The end-user/customer was in her bedroom at the time of the event. She got up to go to the bathroom and fell on her left arm. The user has to go to wound care for several weeks; she did not break any bones.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00038 |
| MDR Report Key | 6457607 |
| Date Received | 2017-04-04 |
| Date of Report | 2017-04-04 |
| Date Facility Aware | 2017-03-10 |
| Report Date | 2017-04-04 |
| Date Reported to FDA | 2017-04-04 |
| Date Added to Maude | 2017-04-04 |
| 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 |
| 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 | 3 |
| Brand Name | CAREX SMALL BASE DESIGNER QUAD CANE - BLACK |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2017-04-04 |
| Model Number | FGA74100 0000 |
| Catalog Number | A741-00 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | N/A |
| Manufacturer Address | N/A N/A N/A US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-04 |