BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROLLATOR

    MDR report key: 2469299 · Received February 15, 2012

    Report

    Report Number
    1417592-2012-00005
    Event Type
    Other
    Date Received
    February 15, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 16, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT A FRONT WHEEL OF THE ROLLATOR BROKE AND HE FELL. WHEN HE FELL, HE BROKE THREE TEETH AND INJURED HIS RIGHT SHOULDER. THE EXTENT OF HIS SHOULDER INJURY IS NOT KNOWN. THE SAMPLE WAS RETURNED AND EVALUATED. THE BRAKES WERE FOUND TO BE ADJUSTED CORRECTLY. THE RIGHT FRONT CASTER WAS STRIPPED AND BENT. FROM THE FLATTENING PATTERN OF THE THREADS, IT APPEARS THE FLATTENING OCCURRED OVER TIME AS OPPOSED TO A SUDDEN BREAKAGE. AS THE THREADS BEGAN TO FLATTEN, THE WHEEL WOULD BECOME WOBBLY. THE OWNER'S MANUAL INSTRUCTS THE END USER NOT TO USE THE DEVICE IF IT IS FOUND TO BE WOBBLY.

    Description of Event or Problem · 1

    WHEEL OF ROLLATOR BROKE AND END USER FELL. HE BROKE THREE TEETH AND INJURED HIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLATOR NONE ITJ MEDLINE INDUSTRIES, INC. G07887B P110145952

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention