BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2851913 · Received November 29, 2012

    Report

    Report Number
    1531186-2012-01527
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 29, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM A DEALER WHO ALLEGED THAT THE LEG BROKE. SHE IS NOT SURE WHERE OR HOW IT HAPPENED. SHE IS GOING TO CALL THE CONSUMER AND GET MORE INFORMATION AS TO HOW IT HAPPENED AND WHERE IT IS BROKEN AT. THERE WAS NO INJURY. IF ANY FURTHER INFORMATION OR SAMPLE IS RECEIVED THE INFORMATION OBTAINED WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 96-2

    Patients

    Seq Age Sex Outcome Treatment
    1 44 Other