MAUDE Adverse Event Report: STANDER STANDER BED RAIL ADVANTAGE TRAVELER

Model Number BED RAIL ADVANTAGE TRAVELLER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Death (1802); Paralysis (1997); Physical Entrapment (2327); Injury (2348)

Event Date 12/22/2011

Event Type  Injury  

Event Description

I bought stander's bed rail advantage traveler in the summer of 2011 from a local store, (b)(6), for my sister, (b)(6), who was a resident in an assisted living facility.On (b)(6) 2011, at approx 7 pm.(b)(6) tried to call the staff by reaching for a pull cord behind her bed.She lost her balance and slipped off the bed.(b)(6) head and right arm became wedged between her bed and the stander bed rail.(b)(6) was left suspended from her bed with her right arm extended outwards.(b)(6) was stuck entrapped for approx seven hours into the early hours of the next day.As a result of this incident, my sister suffered debilitating injuries, including a stress-induced heart attacked (aka "takosubo") and permanent paralysis, which eventually led to her death on (b)(6) 2015.

• Brand Name: STANDER BED RAIL ADVANTAGE TRAVELER
• Type of Device: STANDER BED RAIL ADVANTAGE TRAVELER
• Manufacturer (Section D): STANDER
• MDR Report Key: 5353532
• MDR Text Key: 35517222
• Report Number: MW5059075
• Device Sequence Number: 1
• Product Code: FNJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BED RAIL ADVANTAGE TRAVELLER
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 68 YR