MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for DESIGNER OFFSET CANE ST501R-194 W1345F manufactured by Com-bridge International Co. Ltd..
[120242646]
Patient was going up the steps to her home when her cane bent and she fell forward, bruising her thigh. There were no other injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2018-00003 |
| MDR Report Key | 7874160 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-08-22 |
| Date Facility Aware | 2018-08-23 |
| Report Date | 2018-09-13 |
| Date Reported to Mfgr | 2018-09-13 |
| Date Added to Maude | 2018-09-13 |
| 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 | DESIGNER OFFSET CANE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2018-09-13 |
| Model Number | ST501R-194 |
| Catalog Number | W1345F |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2 YR |
| 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, YULONG 3 ROAD DONG SHENG TOWN ZHONG SHAN CITY, GUANGDONG, 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-13 |