MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for ENDURANCE SEAT CANE 6053 W1450 manufactured by Homecare Enterprise Co. Ltd..
[51187665]
This seat cane which is 5 years old has been in the home care store and broke during a demonstration. Staff is unsure if customer was unfolding it or sitting on it when seat bracket broke. There was no injury and no personal details of the customer were taken. Age and weights are only estimates of average users who have may have tried the unit while it was on the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2016-00008 |
| MDR Report Key | 5847470 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-07-26 |
| Date Facility Aware | 2016-07-28 |
| Report Date | 2016-08-04 |
| Date Reported to FDA | 2016-08-04 |
| Date Reported to Mfgr | 2016-08-04 |
| Date Added to Maude | 2016-08-04 |
| 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 | 2016-08-04 |
| Model Number | 6053 |
| Catalog Number | W1450 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 5 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 | 2016-08-04 |