BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLOT

    MDR report key: 17447592 · Received August 2, 2023

    Report

    Report Number
    3013155768-2023-00010
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Manufacturer
    ENDOCLOT PLUS CO., LTD.
    Product Code
    QAU
    PMA / PMN Number
    K190677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    COULDN'T GET THE POWDER DOWN, CATHETER KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658952 ENDOCLOT PHS QAU ENDOCLOT PLUS CO., LTD. EPK2303-01 A222015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown