BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELED WALKER

    MDR report key: 2439589 · Received January 23, 2012

    Report

    Report Number
    1417592-2012-00002
    Event Type
    Other
    Date Received
    January 23, 2012
    Date of Event
    April 15, 2011
    Report Date
    January 19, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER WAS REPORTED TO BE NAVIGATING HIS PORCH STAIRS WITH THE WALKER. THE WHEELS GOT CAUGHT ON ONE OF THE STAIRS AND THE END USER FELL. HE WAS HOSPITALIZED AND LATER HAD TWO UNK SURGICAL PROCEDURES ON HIS BACK. THE INCIDENT OCCURRED IN (B)(6) 2011, AND HAD NOT PREVIOUSLY BEEN REPORTED. THE SAMPLE WAS DISCARDED BY THE END USER. NO LOT NUMBER OF PHOTOS WERE PROVIDED. HE DID NOT STATE THAT THE WALKER CAUSED THE FALL AND IT WAS INITIALLY REPORTED THAT HE HAD TRIPPED WHILE AMBULATING. THE END USER HAD PRE-EXISTING BACK ISSUES AND HAD BEEN DIAGNOSED WITH ATAXIA. IT WAS NOT CONFIRMED THAT THE FALL CAUSED A SERIOUS INJURY OR THAT IT RESULTED IN THE NEED FOR SURGICAL INTERVENTION. WITHOUT A SAMPLE TO EVALUATE AND IN THE ABSENCE OF ADDITIONAL DETAILS PERTAINING TO THE INCIDENT, A ROOT CAUSE WAS NOT DETERMINED. THE RPTR INDICATED THE END USER MAY NOT HAVE ADEQUATELY LIFTED THE DEVICE ABOVE THE LEVEL OF THE STAIRS. THERE IS NO INFO INDICATING THE WALKER CAUSED THE FALL, HOWEVER, DUE TO THE REPORTED HOSPITALIZATION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE END USER WAS WALKING UP THE STAIRS OF A PORCH WITH THE WALKER AND FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELED WALKER NONE ITJ MEDLINE INDUSTRIES, INC. MDS86410W54 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention