BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142595 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00270
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 17, 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 SERIOUS INJURY ALLEGED. ALLEGED MALFUNCTION. THE CONSUMER'S SON ALLEGES THE ROLLATOR WHEEL BEARING BROKE, CAUSING THE WHEEL TO COME OFF. THE CONSUMER'S SON WAS ABLE TO PREVENT THE CONSUMER FROM FALLING. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION, 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. THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL HISTORY 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, TILING OR TERRAIN ARE UNKNOWN. PRODUCT USAGE TECHNIQUE 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 CONSUMER'S SON ALLEGES THE WHEEL BEARING BROKE, CAUSING THE WHEEL TO COME OFF THE ROLLATOR. THE CONSUMER'S SON WAS ABLE TO PREVENT THE CONSUMER FROM FALLING. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE INM INVACARE 65851R CK090815

    Patients

    Seq Age Sex Outcome Treatment
    1