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

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   Patient Outcome  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.

• Brand Name: BED HANDLES INC.
• Type of Device: BED 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 Key: 496174
• MDR Report Key: 507241
• Event Key: 481123
• Report Number: 507241
• Device Sequence Number: 1
• Product Code: FNJ
• 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 Received: 01/16/2004
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: BA 10W
• OTHER Device ID Number: US 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 FDA: 01/15/2004
• Distributor Facility Aware Date: 01/10/2004
• Device Age: 6 mo
• Event Location: Nursing Home
• Date Report TO Manufacturer: 01/15/2004
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?