MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-12 for ENDURANCE SEAT CANE 6054 W1451 manufactured by Homecare Enterprise Co. Ltd..
[49391687]
Customer was trying out this seat cane in a home medical store when a leg broke. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2016-00006 |
| MDR Report Key | 5787687 |
| Date Received | 2016-07-12 |
| Date of Report | 2016-06-20 |
| Date of Event | 2016-06-20 |
| Date Facility Aware | 2016-06-20 |
| Report Date | 2016-07-12 |
| Date Reported to FDA | 2016-07-12 |
| Date Reported to Mfgr | 2016-07-11 |
| Date Added to Maude | 2016-07-12 |
| 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 SEAT CANE |
| Generic Name | SEAT CANE |
| Product Code | IPS |
| Date Received | 2016-07-12 |
| Model Number | 6054 |
| Catalog Number | W1451 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMECARE ENTERPRISE CO. LTD. |
| Manufacturer Address | NO. 11 CHANGSHENG ST HUATAN TOWNSHIP CHANGHUA COUNTY 50347 TW 50347 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-12 |