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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BED HANDLES INC. BED HANDLES NONE

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BED HANDLES INC. BED HANDLES NONE Back to Search Results
Model Number BA10W
Event Date 03/09/2007
Event Type  Death  
Event Description

Bed handles is bed rail device that has horizontal struts that go under the mattress. At the edge of the bed they turn upward, creating a bed handle. Although coated with a friction coating, there is no other mechanical means to prevent the rail from moving away from the bed with pressure from the patient. In this case, a single rail did move partly away from the bed and, a pt physically frail woman with dementia fell into the space between the vertical rail struts and the mattress, and was held in position by the horizontal struts. She died of asphyxia. The manufacturer has known of this event and failed to file a mandatory report, and apparently has been non compliant with post marketing surveillance in at least one other instance as well.

 
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Brand NameBED HANDLES
Type of DeviceNONE
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 Key1429383
MDR Report Key1366563
Event Key1303494
Report NumberMW5010813
Device Sequence Number1
Product CodeIKX
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 04/17/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberBA10W
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 04/17/2009 Patient Sequence Number: 1
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