BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO ADVANCE

    MDR report key: 19902216 · Received August 3, 2024

    Report

    Report Number
    8021545-2024-02930
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1931115 - MDR 8021545-2024-02930 - DEVICE 1 OF 6. (B)(6).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED 6 INFUSION SETS LEAKAGE AT THE EVENT SITE. THE EVENT WAS IN USE FOR 2 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400046 MIO ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A 6005392 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown