BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED FOR A SPECIFIC MEDICAL USE

    MDR report key: 14547171 · Received May 31, 2022

    Report

    Report Number
    14547171
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 12, 2022
    Manufacturer
    SCIENTIFIC DEVICE LABORATORY, INC.
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    GLASS SLIDES PACKED BY SCIENTIFIC DEVICE - UNABLE TO BE REMOVED FROM PACKAGE IN A STERILE MANNER D/T PACKAGE TEARING, SLIDES STICKING TO THE PACKAGING, AND SLIDES HAVING A RESIDUAL STICKY, WHITE SUBSTANCE ON THEM AFTER REMOVAL. MANUFACTURER: SCIENTIFIC DEVICE, ITEM: STERILE SLIDE FROSTED END, REFERENCE: #050-S, LOT: 042122.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2736167 EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED FOR A SPECIFIC MEDICAL USE LXG SCIENTIFIC DEVICE LABORATORY, INC. 042122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown