BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROLLATOR, SUPER LIGHT, 250 LB CAP

    MDR report key: 2003206 · Received February 16, 2011

    Report

    Report Number
    1417592-2011-00007
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 11, 2011
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT STATES THAT THE WHEEL BROKE WHILE THE END USER WAS WALKING WITH THE ROLLATOR. WHEN THE WHEEL BROKE, THE END USER FELL AND APPARENTLY SUFFERED A FRACTURED ARM. THE DAUGHTER WOULD NOT PROVIDE ADD'L DETAILS PERTAINING TO THE INCIDENT. THE SAMPLE WILL NOT BE RETURNED FOR EVAL. THE ISSUE CANNOT BE CONFIRMED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. HOWEVER, DUE TO THE REPORTED FRACTURE, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE WALKING WITH THE ROLLATOR, THE WHEEL BROKE OFF AND THE END USER FELL, FRACTURING HER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLATOR, SUPER LIGHT, 250 LB CAP NONE ITJ MDS86825SLR A081277828

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention