BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2162419 · Received July 14, 2011

    Report

    Report Number
    1525712-2011-00327
    Date Received
    July 14, 2011
    Date of Event
    June 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    INP
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER WAS USING A ROLLATOR THAT WAS NOT PRESCRIBED FOR HIM. THE ROLLATOR BELONGED TO ANOTHER FAMILY MEMBER. THE CONSUMER WAS WALKING AT AN OUTDOOR AUCTION ON HARD PACKED GRAVEL WHEN HE WENT TO MOVE, THE WHEELS ON THE ROLLATOR ALLEGEDLY GAVE OUT, CAUSING HIM TO FALL TO THE GROUND. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 INP DANYANG MAXTHAI MEDICAL EQUIPMENT MX090815

    Patients

    Seq Age Sex Outcome Treatment
    1 64