BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO¿ ADVANCE

    MDR report key: 19788777 · Received July 21, 2024

    Report

    Report Number
    8021545-2024-02393
    Event Type
    Malfunction
    Date Received
    July 21, 2024
    Date of Event
    June 20, 2024
    Report Date
    October 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017818
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 1863725 - MDR 3003442380-2024-02394. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY:(B)(6).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON (B)(6) 2024, PATIENT COMPLAINED ABOUT INFUSION SET FELL OFF DUE TO TAPE NOT STICKING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004555 MIO¿ ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A UNKNOWN 05705244017818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown