BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORT

    MDR report key: 24754785 · Received April 1, 2026

    Report

    Report Number
    3003442380-2026-06544
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 3, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE (300 MG/DL) EVENT ON (B)(6) 2026. THE PATIENT WAS TREATED WITH CORRECTIONS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819276 COMFORT UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL UM-D MMT-381A 6012821 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention