BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19663561 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11608
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 3, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1901888- MDR 3003442380-2024-11608- DEVICE 2 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 5 INFUSION SET'S ADHESIVE ON (B)(6) 2024. THE PATIENT REPORTED INFUSION SET PATCH LIFTS OFF OF HER SKIN, STARTING WITH THE CANNULA. IT DIDN'T FELL OFF, BUT LIFTED OFF THE SKIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579506 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female