MAUDE Adverse Event Report: BED HANDLES INC.BED HANDLESNONE

Model Number BA10W

Event Date 03/09/2007

Event Type  Death   Patient Outcome  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.

• Brand Name: BED HANDLES
• Type of Device: NONE
• 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: 1429383
• MDR Report Key: 1366563
• Event Key: 1303494
• Report Number: MW5010813
• Device Sequence Number: 1
• Product Code: IKX
• 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 Received: 04/17/2009
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device MODEL Number: BA10W
• 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?