MAUDE Adverse Event Report: SEATED WALKER

Device Problem Device Tipped Over (2589)

Patient Problems Cardiac Arrest (1762); Death (1802); Fall (1848); Head Injury (1879); Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 02/09/2014

Event Type  Death  

Event Description

Accident with a seated walker: while leaving (b)(4), an (b)(6)-year-old man tired of walking and sat down on his seated walker.His adult son began pushing him the rest of the way towards his car, which was parked in a handicapped parking space nearby.The walker's front wheels caught in the seam between the roadway and sidewalk and/or anti-skid bumps on the sidewalk ramp, causing the walker - with the man on it - to tip over backwards in the direction of motion.The man sustained a bleeding injury to the back of his head, lost consciousness, and went into cardiac arrest.Despite cpr by an on-site emt and responding city emts, the man expired in the emergency room at (b)(6), 90 minutes after first falling with the walker.

• Brand Name: SEATED WALKER
• Type of Device: SEATED WALKER
• MDR Report Key: 3651088
• MDR Text Key: 18302455
• Report Number: MW5034715
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 73