BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19482907 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-06972
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    February 1, 2024
    Report Date
    June 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1881884- DEVICE 2 OF 5. E1: PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN ISSUE WITH FIVE INFUSIONS SETS WERE FELL OFF DURING USE ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275309 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male