MAUDE Adverse Event Report: BED HANDLES INC.BEDSIDE ASSISTANTBED RAIL

Model Number BA10W-6

Event Date 02/04/2002

Event Type  Death   Patient Outcome  Death

Event Description

This was the strangulation death of an apparently elderly woman, who was in an assisted living situation. Product was installed on her bed in late 2001 and, she died in 2002 of strangulation in this device, which is described in its patent as in the field of bed rail and handle systems. Manufacturer has known of this death since at least 2005, when legal action filed against it. Manufacturer possibly non complaint with reporting requirement. Dates of use: 2001 - 2002. Diagnosis: prevent bed fall.

• Brand Name: BEDSIDE ASSISTANT
• Type of Device: BED RAIL
• Manufacturer (Section F): BED HANDLES INC.; 2905 sw 19th st.; blue springs MO 64015
• Manufacturer (Section D): BED HANDLES INC.; 2905 sw 19th st.; blue springs MO 64015
• Device Event Key: 1429378
• MDR Report Key: 1366564
• Event Key: 1303495
• Report Number: MW5010814
• Device Sequence Number: 1
• Product Code: IKX
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2009

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/19/2009
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: BA10W-6
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?