BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIEW SAFE

    MDR report key: 16217972 · Received January 20, 2023

    Report

    Report Number
    3005720829-2022-00043
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 20, 2023
    Manufacturer
    CITOTEST LABWARE MANUFACTURING
    Product Code
    KES
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MARKINGS ON THE COVER GLASS SLIP RESEMBLES MONOSODIUM URATE CRYSTALS AND BIREFRINGENT. THIS DEFECT CAN LEAD TO A MISDIAGNOSIS OF GOUT IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895522 VIEW SAFE MICROSCOPE COVER GLASS KES CITOTEST LABWARE MANUFACTURING 210393-032021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other