MAUDE Adverse Event Report: HOMECARE CO. LTD ENDURANCE HOME BED RAIL

Model Number 1304

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

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.

• Brand Name: ENDURANCE HOME BED RAIL
• Type of Device: HOME BED RAIL
• Manufacturer (Section D): HOMECARE CO. LTD; no. 11, chang sheng street; huatan township, changhua county 503 ; TW 503
• Manufacturer (Section G): ESSENTIAL MEDICAL SUPPLY, INC.; 6420 hazeltine national dr.; orlando FL 32822
• Manufacturer Contact: 6420 hazeltine national dr.; orlando, FL 32822
• MDR Report Key: 4034901
• MDR Text Key: 4724463
• Report Number: 1056127-2014-00014
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1304
• Device Catalogue Number: P1460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2014
• Distributor Facility Aware Date: 07/28/2014
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 08/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 86