BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19275137 · Received May 9, 2024

    Report

    Report Number
    3003442380-2024-00944
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Report Date
    May 9, 2024
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT A 13-YEAR-OLD FEMALE CHILD PATIENT FACED A BLOCKAGE AT THE SITE AND EXPERIENCED HIG KETONE LEVELS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547293 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown