MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-05 for ENDURANCE QUAD CANE ST801-S W1301S manufactured by Combridge International Company, Ltd..
[63975316]
Patient was using a small base quad cane when the upper shaft broke at the third adjustment hole. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2017-00001 |
| MDR Report Key | 6226138 |
| Date Received | 2017-01-05 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-09-17 |
| Date Facility Aware | 2016-12-09 |
| Report Date | 2017-01-05 |
| Date Reported to FDA | 2017-01-05 |
| Date Reported to Mfgr | 2016-12-19 |
| Date Added to Maude | 2017-01-05 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | ENDURANCE QUAD CANE |
| Generic Name | SMALL BASE QUAD CANE |
| Product Code | IPS |
| Date Received | 2017-01-05 |
| Returned To Mfg | 2017-01-05 |
| Model Number | ST801-S |
| Catalog Number | W1301S |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMBRIDGE INTERNATIONAL COMPANY, LTD. |
| Manufacturer Address | UNIT 1, NO. 66 YULONG 3 ROAD DONG SHENG TOWN ZHONG SHANG CITY, GUANGDONG 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-05 |