BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLOT

    MDR report key: 20072752 · Received August 26, 2024

    Report

    Report Number
    3013155768-2024-00015
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Manufacturer
    ENDOCLOT PLUS CO., LTD.
    Product Code
    BTI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE AWAITING TO RECEIVE THE DAMAGED DEVICE THROUGH THE DISTRIBUTOR TO PERFORM INVESTIGATION OF THIS CASE.

    Description of Event or Problem · 0

    USER PLACING BATTERIES INTO EQUIPMENT, IT IMMEDIATELY SPARKED, SMALL FLAME. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968113 ENDOCLOT ENDOCOT AIR COMPRESSOR, PORTABLE BTI ENDOCLOT PLUS CO., LTD. EPAC-2 D122075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown