BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19678121 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-11811
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    April 20, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026063
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1903533 - MDR 3003442380 - 2024 - 11811 - DEVICE 7 OF 10.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT TEN INFUSION SET WAS FELL OFF DURING USE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133782 AUTOSOFT XC INSET I 2-PACK 12/6 GREY TCAP FPA UNOMEDICAL A/S 1009566 6004833 05705244026063

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male