BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2031665 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00124
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 18, 2011
    Manufacturer
    UNK
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. THE CONSUMER REPORTEDLY WAS ON THE ROLLATOR WHEN ONE OF THE WHEELS GAVE WAY AND HE FELL TO THE FLOOR. IF THE CASTER WAS PERMITTED TO LOOSEN, IMPROPER MAINTENANCE OF THIS TYPE CAN RESULT IN BENDING AND EVENTUAL FRACTURE OF A STEM BOLT. CURRENT USER GUIDES COVER THIS AREA. USER ERROR/IMPROPER MAINTENANCE IS LIKELY CAUSE OF THIS INCIDENT. MALFUNCTION IS NOT CONFIRMED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE SEAT OF THE ROLLATOR WHEN ONE OF THE SWIVEL WHEELS ALLEGEDLY GAVE WAY, CAUSING HIM TO FALL TO THE FLOOR. THE CONSUMER CALLED 911 AND WAS EVALUATED, BUT DI D NOT GO TO THE HOSP. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.2825 ITJ UNK 66500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1