BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2031917 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00125
    Event Type
    Other
    Date Received
    March 22, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 18, 2011
    Manufacturer
    UNK
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER STATED HE GOT UP THEN SAT BACK DOWN ON THE SEAT OF THE ROLLATOR, AND REPORTEDLY FELL. AFTER THE FALL, THE USER NOTICED THE FRAME IS NOW CROOKED. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN/IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. THE CONSUMER ALLEGEDLY HAD X-RAYS TAKEN AND NO SERIOUS INJURY IS REPORTED. MALFUNCTION IS NOT CONFIRMED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. MDR FILED BASED ON MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE CONSUMER STATES HE GOT UP AND THEN SAT BACK DOWN ON THE SEAT OF THE ROLLATOR WHEN HE ALLEGEDLY FELL AND THE FRAME OF THE ROLLATOR WAS ALLEGEDLY CROOKED. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNK 65100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR