BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2120468 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00230
    Event Type
    Other
    Date Received
    June 3, 2011
    Report Date
    June 2, 2011
    Manufacturer
    INVACARE
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. USER WAS GOING DOWN A HILL WHEN SHE HIT A BUMP AND BENT THE FRAME. CONSUMER CONTINUED TO USE THE PRODUCT AND EVENTUALLY BROKE THE LEFT SIDE OF THE ROLLATOR. 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. IN THIS INCIDENT, CONTINUED USE OF A PRODUCT WITH A KNOWN BENT FRAME MOST LIKELY CAUSED THE EVENTUAL LEFT SIDE TO BREAK. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER'S HUSBAND ALLEGES THEY WERE GOING DOWNHILL WHEN SHE WENT OVER A BUMP IN THE ROAD AND THE FRAME BENT IN THE MIDDLE. AT A LATER DATE, THE FRAME ALLEGEDLY BROKE ON THE LEFT SIDE. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ INVACARE 65650 MX100515

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR