BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLOT

    MDR report key: 20062568 · Received August 26, 2024

    Report

    Report Number
    3013155768-2024-00008
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    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

    CUSTOMER CALLED TO REQUEST A CREDIT FOR THIS UNIT BECAUSE IT DID NOT DEPLOY DURING THE PROCEDURE. NO PATIENT INJURY. DOCTOR SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOHTER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159077 ENDOCLOT ENDOCLOT PHS QAU ENDOCLOT PLUS CO., LTD. EPK2303-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown