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U.S. Department of Health and Human Services

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

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BED HANDLES INC. BEDSIDE ASSISTANT BED RAIL Back to Search Results
Model Number BA10W-6
Event Date 02/04/2002
Event Type  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.

 
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Brand NameBEDSIDE ASSISTANT
Type of DeviceBED 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 Key1429378
MDR Report Key1366564
Event Key1303495
Report NumberMW5010814
Device Sequence Number1
Product CodeIKX
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 Received04/19/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberBA10W-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?

Patient TREATMENT DATA
Date Received: 04/19/2009 Patient Sequence Number: 1
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