BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142616 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00277
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 20, 2011
    Manufacturer
    INVACARE
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGED SERIOUS INJURY. ALLEGED MALFUNCTION. ALLEGEDLY, THE CONSUMER WAS USING THE ROLLATOR WHEN IT COLLAPSED, CAUSING THE FRONT STEM AREA TO COLLAPSE IN A 90 DEGREE ANGLE BACK TOWARDS THE CONSUMER. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION AND STABILITY ARE UNKNOWN. THE CONSUMER'S MEDICATION REGIMEN IS UNKNOWN. ANY ADDITIONAL LOADING TO THE DEVICE IS UNKNOWN. THE ENVIRONMENTAL CONDITIONS FOR THE FLOORING, CARPETING OR TILING ARE UNKNOWN. THE CONSUMER'S POSITION STANDING OR SITTING IS UNKNOWN. NOTE: THIS PRODUCT IS NOT MEANT TO MIMIC A WHEELCHAIR IN ITS USE. IT IS FOR WALKING SUPPORT AND STATIONARY RESTING; BEING PUSHED OR SELF PROPELLING WHILE SEATED IS NOT ITS INTENDED USE.

    Description of Event or Problem · 1

    THE ROLLATOR ALLEGEDLY COLLAPSED, CAUSING THE FRONT STEM AREA TO COLLAPSE IN A 90 DEGREE ANGLE BACK TOWARDS HER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE INM INVACARE 65850 NA

    Patients

    Seq Age Sex Outcome Treatment
    1