BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 19525326 · Received June 12, 2024

    Report

    Report Number
    3003442380-2024-07643
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1885090 - MDR 3003442380-2024-07643 - DEVICE 2 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED EVENTS OF OCCLUSION AT INFUSION SET SITE WITH THREE INFUSION SETS. THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT THE ABDOMEN. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937737 INSET INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 UNKNOWN 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male