BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2932068 · Received January 28, 2013

    Report

    Report Number
    1531186-2013-00337
    Date Received
    January 28, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 28, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    A FAMILY MEMBER ALLEGES THE WALKER BROKE ON THE LEFT SIDE AS HIS MOTHER WAS USING IT. ALSO STATED THE LEFT SIDE WOULD NOT MOVE. END USER'S ON STATED THAT ABOUT 6 MONTHS AGO HE PUT BIGGER WHEELS ON THE WALKER TO MAKE IT MORE STABLE. REPORTEDLY THE WALKER COLLAPSED DURING USE. SON STATED THAT THE WALKER SEEMS TO MOVE ABOUT 5 INCHES AT THE BOTTOM LEFT AND IT WAS NEVER WELL ALIGNED. MOTHER WAS BRUISED AND REMAINED FOR AN EXTENDED PERIOD OF TIME ON THE FLOOR. NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38351 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6231-A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other