MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-08-19 for ENDURANCE HOME BED RAIL 1304 P1460 manufactured by Homecare Co. Ltd.
[4724463]
A release pin for a home bed rail had come loose and was missing; pt's relative replaced the quick release pin with a permanent bolt which prohibited the rail from raising and lowering. As a result, the pt used it to transfer in and out of the bed and the relative reported that the pt put excessive force on the hand rail. Over time the weld on one of the two male extension bars failed. There was no injury and no fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2014-00014 |
| MDR Report Key | 4034901 |
| Report Source | 99 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-05-28 |
| Date Facility Aware | 2014-07-28 |
| Report Date | 2014-07-28 |
| Date Reported to FDA | 2014-08-19 |
| Date Reported to Mfgr | 2014-08-15 |
| Date Added to Maude | 2014-08-26 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDURANCE HOME BED RAIL |
| Generic Name | HOME BED RAIL |
| Product Code | FNJ |
| Date Received | 2014-08-19 |
| Model Number | 1304 |
| Catalog Number | P1460 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMECARE CO. LTD |
| Manufacturer Address | NO. 11, CHANG SHENG STREET HUATAN TOWNSHIP, CHANGHUA COUNTY 503 TW 503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-19 |