BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19527443 · Received June 13, 2024

    Report

    Report Number
    3003442380-2024-08127
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 13, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018488
    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 1895251 - MDR 3003442380-2024-08127 - DEVICE 4 OF 10. E1: PATIENT CITY: (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TEN INFUSION SETS OCCLUSION AT SITE EVENTS IN THE PAST WEEK. THE INSERTION SITE WAS AT THIGH, UPPER BUTTOCKS, STOMACH AND BACK OF ARM AND PATIENT RESOLVED ALL THE EVENTS BY CHANGING THE SUPPLIES. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864157 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002835 5397720 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female