MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-31 for CAREX FGA74100 0000 manufactured by Aid-pro Healthcare Co., Ltd..
[131716863]
The end-user sustained severe & disfiguring personal injuries when the base of a quad cane lacerated her leg. Information regarding the model number of the quad cane has not been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00067 |
| MDR Report Key | 8206266 |
| Date Received | 2018-12-31 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-08-27 |
| Date Facility Aware | 2019-01-08 |
| Report Date | 2019-01-18 |
| Date Reported to FDA | 2019-01-18 |
| Date Reported to Mfgr | 2019-01-18 |
| Date Added to Maude | 2018-12-31 |
| 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 | CANE |
| Product Code | IPS |
| Date Received | 2018-12-31 |
| Model Number | FGA74100 0000 |
| 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 HEALTHCARE CO., LTD. |
| Manufacturer Address | NO. 58 YU LONG 3 ROAD DONG SHENG TOWN ZHONG SHAN CITY, CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-12-31 |