BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2100341 · Received May 12, 2011

    Report

    Report Number
    1525712-2011-00193
    Event Type
    Other
    Date Received
    May 12, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 10, 2011
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER ALLEGES THE ROLLATOR FOLDED UP WHILE SHE WAS WALKING WITH THE UNIT AND SHE FELL. IT IS UNKNOWN IF THE CONSUMER HAD THE ROLLATOR IN THE FULLY OPEN POSITION. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN / IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. MALFUNCTION HAS NOT BEEN ESTABLISHED. MDR FILED BASED ON ALLEGATION OF MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER WAS WALKING TO THE CAR WHEN THE WALKER ALLEGEDLY FOLDED UP IN FRONT OF HER. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR