BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROLLATOR

    MDR report key: 2925231 · Received January 11, 2013

    Report

    Report Number
    1417592-2013-00003
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 7, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT HER FRIEND WAS MOVING THE DEVICE AND A WHEEL CAME OFF. HE FELL, HITTING HIS HEAD AND HAD A TEMPORARY LOSS OF CONSCIOUSNESS. HE WAS EVALUATED BY THE PARAMEDICS BUT DID NOT GO TO THE EMERGENCY ROOM. NO TREATMENT WAS PROVIDED. THE SAMPLE WAS RETURNED AND THE ISSUE WAS CONFIRMED. ITS CONDITION WAS WORN WITH DIRT AND VARIOUS RESIDUE PRESENT THROUGHOUT. THERE WERE DENTS ALONG THE FRONT CROSSBAR INDICATING THAT THE DEVICE HAD BEEN SUBJECTED TO VARIOUS EXTERNAL IMPACTS THROUGHOUT ITS USAGE. NO MAINTENANCE HAD BEEN PERFORMED ON THE DEVICE DURING THE SIX YEARS IT HAD BEEN USED AND WE HAVE DETERMINED THAT THE LACK OF MAINTENANCE IS LIKELY TO BE A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    A FRIEND OF THE END USER WAS MOVING THE ROLLATOR. A WHEEL CAME OFF AND HE FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17755 ROLLATOR ITJ MEDLINE INDUSTRIES, INC. R061230488

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other