MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for CAREX ERGO OFFSET CANE - BLUE FLOWER FGA58500 0000 N/A manufactured by Com-bridge International Co., Ltd.
[67835150]
The end-user states that she was walking from her car to her house, and the cane collapsed. She fell on her knee, and then rolled to her hip. She had x-rays, and now the doctor states that she shattered the ball of her hip and will need surgery. She stated the lock pin was securely in place on the cane. The device is reported as having been used on grass with its rubber feet free of splits, cracks or tears. The device is reported as having used the cane for 6 months. She has two of the same cane, and is not sure which cane she fell with, as they are identical, with self-standing cane tips on both - she is having both canes returned to compass health brands just in case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00016 |
| MDR Report Key | 6345383 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-21 |
| Date of Event | 2017-01-15 |
| Date Facility Aware | 2017-01-27 |
| Report Date | 2017-02-21 |
| Date Reported to FDA | 2017-02-21 |
| Date Reported to Mfgr | 2017-02-21 |
| Date Added to Maude | 2017-02-21 |
| 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 ERGO OFFSET CANE - BLUE FLOWER |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2017-02-21 |
| Model Number | FGA58500 0000 |
| Catalog Number | N/A |
| 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 | COM-BRIDGE INTERNATIONAL CO., LTD |
| Manufacturer Address | UNIT 1, NO 66 YU LONG 3 ROAD DONG SHENG TOWN ZHONG SHAN CITY, GUANGDONG 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-02-21 |