BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 24656826 · Received March 21, 2026

    Report

    Report Number
    8021545-2026-02022
    Event Type
    Injury
    Date Received
    March 21, 2026
    Date of Event
    February 18, 2026
    Report Date
    February 20, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: SAN MARINO REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SAN MARINO IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA ON (B)(6)2026 AFTER ADMINISTERING A BOLUS 15 MINUTES PRIOR TO THE MEAL AND WAS TREATED WITH 5 SACHETS OF SUGAR. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717835 INSET GUARD UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A UNKNOWN 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention