BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2126487 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00224
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    April 8, 2011
    Report Date
    June 2, 2011
    Manufacturer
    INVACARE
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER WAS USING THE ROLLATOR AND SAT DOWN ON THE SEAT, WHEN UNIT ALLEGEDLY COLLAPSED AND HE FELL TO THE GROUND. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN / IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE OCCURRED. NO SERIOUS INJURY HAS BEEN REPORTED. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER STATES WHEN HE SAT ON THE SEAT OF THE ROLLATOR, THE SEAT ALLEGEDLY COLLAPSED, CAUSING HIM TO FALL TO THE GROUND. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ INVACARE 65650R MX091215

    Patients

    Seq Age Sex Outcome Treatment
    1