BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRON IT26-C

    MDR report key: 20180306 · Received September 10, 2024

    Report

    Report Number
    3013145340-2024-00027
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    January 19, 2022
    Report Date
    September 10, 2024
    Manufacturer
    TERRAGENE S.A.
    Product Code
    JOJ
    UDI-DI
    07798164679622
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS. RETAIN TESTING WAS PERFORMED ON THE LOT NUMBER SUBJECT OF THE REPORTED EVENT; THE RESULTS OBTAINED BY THE USER COULD NOT BE REPLICATED. THE LOT PERFORMED AS ESTABLISHED. THE DHR FOR THE SUBJECT LOT WAS REVIEWED AND NO ABNORMALITIES WERE FOUND.

    Description of Event or Problem · 0

    USER FACILITY INFORMED THAT THE INTEGRON IT26-C BURST AFTER A COMPLETE STERILIZATION CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226107 INTEGRON IT26-C CHEMICAL INDICATOR JOJ TERRAGENE S.A. INTEGRON IT26-C 19039 07798164679622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown