BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROLLATOR

    MDR report key: 2577667 · Received May 10, 2012

    Report

    Report Number
    1417592-2012-00032
    Event Type
    Other
    Date Received
    May 10, 2012
    Date of Event
    April 5, 2012
    Report Date
    May 7, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA EMAIL THAT ONE OF THE TRIANGULAR HAND SCREWS WAS FOUND TO BE STRIPPED. DESPITE THIS, THE END USER CONTINUED TO USE THE DEVICE. DURING USE, ONE LEG OF THE DEVICE RETRACTED INTO THE FRAME AND THE END USER ALLEGEDLY FELL AND SUFFERED A HERNIATED DICS. WE WERE UNABLE TO GATHER ADD'L DETAILS AS THE HUSBAND DECLINED REQUESTS TO SPEAK WITH US. THE WEIGHT OF THE END USER IS NOT KNOWN. IT IS NOT KNOWN WHY SHE WAS USING THE ROLLATOR, IF IT HAD BEEN MAINTAINED OR FOR HOW LONG SHE HAD IT. THE SAMPLE WAS RETURNED AND EVALUATED. ONE OF THE TRIANGULAR HAND SCREWS WAS BENT AND FOUND TO BE STRIPPED. THE OWNER'S MANUAL INDICATES THE TRIANGULAR KNOBS SHOULD BE SECURE. A STRIPPED KNOB CANNOT BE SECURED AND THIS WOULD BE APPARENT TO AN END USER.

    Description of Event or Problem · 1

    END USER FELL WHILE USING THE DEVICE AND SUFFERED A HERNIATED DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLATOR ITJ MEDLINE INDUSTRIES, INC. MDS86835 A100923269

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention