• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BED HANDLES, INC.THE ORIGINAL BED HANDLE - BEDSIDE ASSISTANTBEDISDE ASSISTANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

BED HANDLES, INC. THE ORIGINAL BED HANDLE - BEDSIDE ASSISTANT BEDISDE ASSISTANT   Back to Search Results
Model Number BA10W
Device Problems Dislodged; Unknown (for use when the device problem is not known)
Event Date 03/27/1999
Event Type  Death   Patient Outcome  Death
Event Description

Nursing assistant noted resident draped over the bedside assistant with no response, no pulse or respiration. The bedside assist (a 1 piece continuous device) was dislodged 12-18 inches at the distal end. The resident was found draped over the distal leg that was protruding 12-18 inches from the bed. The resident was on comfort care due to decline in condition. She used the bedside assist to participate in bed mobility.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTHE ORIGINAL BED HANDLE - BEDSIDE ASSISTANT
Type of DeviceBEDISDE ASSISTANT
Manufacturer (Section F)
BED HANDLES, INC.
4825 south tierney drive
independence MO 64055
Manufacturer (Section D)
BED HANDLES, INC.
4825 south tierney drive
independence MO 64055
Device Event Key211495
MDR Report Key218072
Event Key204612
Report Number218072
Device Sequence Number1
Product CodeFNJ
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberBA10W
OTHER Device ID NumberPATENT 5,471,689
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/08/1999
Distributor Facility Aware Date04/07/1999
Device Age2 mo
Event Location Nursing Home
Date Report TO Manufacturer04/08/1999
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

-
-