BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2120491 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00229
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 2, 2011
    Manufacturer
    INVACARE
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY REPORTED. USER WAS GOING DOWN A HILL WHEN THE BRAKE ALLEGEDLY FAILED. PRODUCT WAS APPROXIMATELY 7 MONTHS OLD AT TIME OF INCIDENT. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN / IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER WAS GOING DOWN A HILL WHEN THE LEFT BRAKE ALLEGEDLY FAILED, CAUSING HIM TO FALL DOWN. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ INVACARE 65650 MX100915

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR