BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19583461 · Received June 21, 2024

    Report

    Report Number
    3003442380-2024-09404
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    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 1892648- MDR 3003442380-2024-09404- DEVICE 6 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(6). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED A LEAKAGE ONTO ADHESIVE ON (B)(6) 2024. MOREOVER, THE ISSUE OCCURRED WITH SIX SIMILAR TYPES OF INFUSION SETS USED FOR TWELVE HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157600 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 UNKNOWN 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female