BEUDAMED
    FDA Adverse Event Other Summary report: N

    UF1000I

    MDR report key: 3071010 · Received April 11, 2013

    Report

    Report Number
    1217157-2013-00063
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    SYSMEX 577
    Product Code
    LKM
    PMA / PMN Number
    K070910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS CONTACTED THE MANUFACTURER OF THIS DEVICE TO INFORM THEM OF THIS ERROR.

    Description of Event or Problem · 1

    THE INSTRUCTIONS FOR USE FOR THIS DEVICE INDICATE THAT THE LASER IS A CLASS I WHEREAS THE LASER IN THE DEVICE IS A CLASS 3B. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155391 UF1000I NONE LKM SYSMEX 577

    Patients

    Seq Age Sex Outcome Treatment
    1