MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-05 for ENDURANCE FOLDING SEAT CANE 6053 W1450 manufactured by Homecare Co. Ltd No. 11.
[5837709]
While putting the seat cane in his truck, the user noticed a break in the leg where through bolt attaches the legs. There was no fall or injury. He reported that this is the second such device that had the same problem. He did not previously report a problem as there was no adverse effect with it either.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2015-00012 |
| MDR Report Key | 4827652 |
| Date Received | 2015-06-05 |
| Date of Report | 2015-05-13 |
| Date of Event | 2015-05-13 |
| Date Facility Aware | 2015-05-13 |
| Report Date | 2015-05-13 |
| Date Reported to FDA | 2015-06-05 |
| Date Reported to Mfgr | 2015-06-04 |
| Date Added to Maude | 2015-06-11 |
| 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 |
| Manufacturer Street | 6420 HAZELTINE NATIONAL DR. |
| Manufacturer City | ORLANDO FL 32822 |
| Manufacturer Country | US |
| Manufacturer Postal | 32822 |
| Manufacturer G1 | ESSENTIAL MEDICAL SUPPLY, INC. |
| Manufacturer Street | 6420 HAZELTINE NATIONAL DR. |
| Manufacturer City | ORLANDO FL 32822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32822 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDURANCE FOLDING SEAT CANE |
| Generic Name | SEAT CANE |
| Product Code | IPR |
| Date Received | 2015-06-05 |
| Model Number | 6053 |
| Catalog Number | W1450 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMECARE CO. LTD NO. 11 |
| Manufacturer Address | CHANG SHENG ST HUATAN TOWNSHIP CHANGUA COUNTY R.O.C. TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-05 |