BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3114783 · Received May 15, 2013

    Report

    Report Number
    1525712-2013-03853
    Date Received
    May 15, 2013
    Report Date
    April 20, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES NOTHING SEEMS WRONG WITH THE WALKER. END USER IS MY MOTHER IN LAW AND IS IN A NURSING HOME. SHE IS NOT SUPPOSE TO GET UP AND MOVE BY HERSELF, BUT, DID. SHE USES AMHERST MANOR NURSING HOME'S INVACARE WALKER WITH NON INVACARE TENNIS BALLS ON THE FRONT AND NON INVACARE SKIDS ON THE BACK TO GO TO THE BATHROOM AND SOMEHOW FELL IN THE BATHROOM AND GOT STUCK BETWEEN THE TOILET AND THE WALL FOR UNKNOWN PERIOD OF TIME UNTIL THE NURSING HOME STAFF FOUND HER. SHE WAS TRANSPORTED TO AMHERST ER AND THEN ADMITTED TO EMH. NO REPORTS OF HEAD INJURY. MINOR KNEE INJURY. MAIN REASON SHE WAS ADMITTED TO EMH WAS DUE TO SKIN INFECTION THAT IS NOT A RESULT OF THE INCIDENT, BUT, WAS INCIDENTAL FINDING AT ER. KNEE X-RAYS WERE NEGATIVE. SHE IS UNABLE TO GIVE ANY ACCURATE DESCRIPTION OF WHAT HAPPENED OR HOW SHE FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215197 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 Other