BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO¿ ADVANCE

    MDR report key: 19769817 · Received July 18, 2024

    Report

    Report Number
    8021545-2024-02218
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 19, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018907
    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 1915870 - MDR 8021545-2024-02218 - DEVICE 1 OF 2 E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: SPAIN.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET TAPE NOT STICKING EVENT ON 18-JUN-2024. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149157 MIO¿ ADVANCE UNO MIO ADV. GREY 60/9 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-243A UNKNOWN 05705244018907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown