BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAC LARYNGOSCOPE BLADES

    MDR report key: 19381676 · Received May 22, 2024

    Report

    Report Number
    MW5155278
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 20, 2024
    Manufacturer
    PROPPER MFG. CO., INC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LARYNGOSCOPE BLADES PEELED, FLAKED, AND THE BOND SEPARATED. THIS WAS DISCOVERED WHEN THE LARYNGOSCOPES WERE STERILIZED PRIOR TO USE ON A PATIENT. THE PRODUCT DEFECTS WERE DISCOVERED AND NEVER PUT INTO USE. NO PATIENTS WERE AFFECTED. MODEL NUMBERS: 19916100,199144,199145,199146. " UDI NUMBER: (B)(4)". REFERENCE REPORTS: MW5155274, MW5155275, MW5155276, MW5155277, MW5155279.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300032 MAC LARYNGOSCOPE BLADES LARYNGOSCOPE, RIGID CCW PROPPER MFG. CO., INC. DJ12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown