BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIOÂ ADVANCE

    MDR report key: 19741077 · Received July 15, 2024

    Report

    Report Number
    8021545-2024-02150
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 14, 2024
    Report Date
    October 21, 2025
    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 1913539 - MDR 8021545-2024-02150 - DEVICE 5 OF 5. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: NETHERLANDS.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN NETHERLANDS. IT WAS REPORTED THAT PATIENT FACED 5 INFUSIONS SET LEAKAGE AFTER ONE DAY EVENT ON 14-JUN-2024.INFUSION SET HAS BEEN USED FOR 2 DAYS. LOCATION OF THE LEAK AT SKIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458196 MIOÂ ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A 6004282 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown