BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRON IT26-C

    MDR report key: 19640729 · Received June 30, 2024

    Report

    Report Number
    3013145340-2024-00026
    Event Type
    Malfunction
    Date Received
    June 30, 2024
    Date of Event
    October 26, 2021
    Report Date
    June 27, 2024
    Manufacturer
    TERRAGENE S.A.
    Product Code
    JOJ
    UDI-DI
    07798164679622
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DISTRIBUTOR, THERE WAS NO KNOWN REPORTABLE EVENT THAT OCCURRED. ONE INDICATOR SHOWED BLEEDING OF THE INK AND THE USER HAD TO REPROCESS THE LOAD. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS.

    Description of Event or Problem · 0

    A USER FACILITY INFORMED THAT THE INTEGRON IT26-C CI HAS LEAKAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191722 INTEGRON IT26-C CHEMICAL INDICATOR JOJ TERRAGENE S.A. INTEGRON IT26-C 19039 07798164679622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown