BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON AURORA FOUR

    MDR report key: 12663497 · Received October 20, 2021

    Report

    Report Number
    3006437518-2021-00004
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 16, 2021
    Report Date
    September 21, 2021
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FTA
    PMA / PMN Number
    K071698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, DKK WAS INFORMED THAT PAINT OF THE VSTS AND BOMS OF THE SKYTRON AUA5 AND AUA5TV HAD BECOME CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567225 SKYTRON AURORA FOUR LIGHT, SURGICAL, ACCESSORIES FTA DAI-ICHI SHOMEI CO., LTD. AUA5LH & AUA5TVLH

    Patients

    Seq Age Sex Outcome Treatment
    1