BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO¿ ADVANCE

    MDR report key: 19894180 · Received August 2, 2024

    Report

    Report Number
    8021545-2024-02838
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). PATIENT COUNTRY: CANADA.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT PATIENT FACED INFUSIONS SET LEAKAGE AT SITE EVENT ON 02-JUL-2024. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884468 MIO¿ ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown