BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKER

    MDR report key: 3161536 · Received May 5, 2013

    Report

    Report Number
    1417592-2013-00050
    Event Type
    Injury
    Date Received
    May 5, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WIFE REPORTED THAT HER HUSBAND ROSE FROM A SITTING POSITION, STARTED WALKING AND FELL. HE FRACTURED HIS WRIST. SHE STATED THE FALL WAS NOT WITNESSED. THE FOLDING MECHANISM ON THE TOP OF THE WALKER APPARENTLY CAME OFF AND THE WALKER COLLAPSED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE SENT. THE OVERALL CONDITION OF THE DEVICE IS NOT KNOWN. WE DO NOT KNOW IF THE DEVICE WAS FULLY SECURE IN THE OPEN POSITION PRIOR TO THE INCIDENT. WE HAVE NO TREND FOR THIS ISSUE WITH THIS DEVICE. A ROOT CAUSE HAS NOT BEEN DETERMINED BUT WE CANNOT RULE OUT THE POSSIBILITY THAT THE END USER MAY HAVE FALLEN ONTO THE WALKER.

    Description of Event or Problem · 1

    THE END USER WAS RISING FROM A SITTING POSITION AND FELL WHEN THE FOLDING BUTTON CAME OFF AND THE WALKER COLLAPSED. HE FRACTURED HIS WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196177 WALKER ITJ MEDLINE INDUSTRIES, INC. C101190164

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention