BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLOT

    MDR report key: 17447593 · Received August 2, 2023

    Report

    Report Number
    3013155768-2023-00009
    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 Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE USER DIDN'T NOT TURN ON AIR COMPRESSOR PRIOR INSERTION OF CATHETER AS INSTRUCTED BY THE IFU. THE CATHETER GOT LIQUID INSIDE AND OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658953 ENDOCLOT PHS QAU ENDOCLOT PLUS CO., LTD. EPK2303-01 A222015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown