MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-03-18 for ENDURANCE FOREARM CRUTCH ST601A W4102 manufactured by Com-bridge International Co., Ltd..
[4252920]
Pt told dealer that he had noticed that a cuff on one of the pair of his forearm crutches was loose and he continued to use it until it separated completely. When the crutches were returned to the dealer one of the pair did show the separation. There was no similar problem with the second.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2014-00004 |
| MDR Report Key | 3713735 |
| Report Source | 99 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-20 |
| Date Facility Aware | 2014-02-20 |
| Report Date | 2014-03-18 |
| Date Reported to FDA | 2014-03-18 |
| Date Reported to Mfgr | 2014-03-17 |
| Date Added to Maude | 2014-04-01 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDURANCE FOREARM CRUTCH |
| Generic Name | FOREARM CRUTCH |
| Product Code | INP |
| Date Received | 2014-03-18 |
| Model Number | ST601A |
| Catalog Number | W4102 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COM-BRIDGE INTERNATIONAL CO., LTD. |
| Manufacturer Address | NO. 50 YONG HUA ROAD DONG SHEN TOWN ZHONG SHAN CITY, GUANG DONG PROVINCE CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-18 |