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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BED HANDLES INC. BED HANDLES INC. BED MOBILITY BARS

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BED HANDLES INC. BED HANDLES INC. BED MOBILITY BARS Back to Search Results
Model Number BA 10W
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 01/10/2004
Event Type  Death  
Event Description

Resident found laying on left side on floor with head and left arm wedged in mobility bar. Resident had no pulse and no respirations or b/p.

 
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Brand NameBED HANDLES INC.
Type of DeviceBED MOBILITY BARS
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 Key496174
MDR Report Key507241
Event Key481123
Report Number507241
Device Sequence Number1
Product CodeFNJ
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/12/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberBA 10W
OTHER Device ID NumberUS PATENT 5,471,689
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2004
Distributor Facility Aware Date01/10/2004
Device Age6 mo
Event Location Nursing Home
Date Report TO Manufacturer01/15/2004
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: 01/16/2004 Patient Sequence Number: 1
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