BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19770279 · Received July 18, 2024

    Report

    Report Number
    3003442380-2024-14718
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    April 25, 2024
    Report Date
    July 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    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 - 1914985- MDR 3003442380-2024-14718 - DEVICE 4 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 25-APRIL-2024, IT WAS REPORTED THAT PATIENT EXPERIENCED ISSUE WITH FOUR INFUSION SETS AS THEY FELL OFF DURING USE. THE EVENT OCCURRED WITHIN 2 DAYS AFTER INSERTION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145042 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 UNKNOWWN 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female