BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX HANDLE,STANDARD,DISP.,CURAVIEW FO,GREEN SYSTEM

    MDR report key: 18324145 · Received December 14, 2023

    Report

    Report Number
    18324145
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 29, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS WEEK, WE¿VE RECEIVED TWO REPORTS REGARDING THE SAME LOT OF CURAVIEW HANDLES THAT ARE DIMMING BEFORE OR DURING INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245037 CURAPLEX HANDLE,STANDARD,DISP.,CURAVIEW FO,GREEN SYSTEM LARYNGOSCOPE, RIGID CCW BOUND TREE MEDICAL, LLC 301-FO-S 201110C0326 / 230223C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown