BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 7734570 · Received July 31, 2018

    Report

    Report Number
    3006437518-2015-00008
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Report Date
    May 29, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, DAI-ICHI SHOMEI RECEIVED INFORMATION THAT DURING A PROCEDURE, THE LENS OF THE CAMERA COVER FELL ON THE STERILIZED SITE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579539 SKYTRON CAMERA COVER KQM DAI-ICHI SHOMEI CO., LTD B1-710-57-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown