BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARYNGOSCOPE BLADES

    MDR report key: 19381360 · Received May 22, 2024

    Report

    Report Number
    MW5155269
    Event Type
    Malfunction
    Date Received
    May 22, 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. "UDI NUMBER (B)(4)". MODEL NUMBERS: "199160,199158,199159,19156,19157". REFERENCE REPORTS: MW5155266, MW5155267, MW5155268, MW5155270, MW5155271, MW5155272, MW5155273.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300023 LARYNGOSCOPE BLADES LARYNGOSCOPE, RIGID CCW PROPPER MFG. CO., INC. EB89

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown