BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 25090493 · Received May 6, 2026

    Report

    Report Number
    8021545-2026-06101
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 8, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: WICKLOW TOWN. PATIENT COUNTRY: IRELAND . NAME: MEDTRONIC MINIMED. COUNTRY: UNITED STATES OF AMERICA. STREET: 18000 DEVONSHIRE STREET. CITY: NORTHRIDGE. STATE: CA. ZIP CODE: 91325 ¿ 1219. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 8021545. MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FACED HIGH BLOOD GLUCOSE LEVEL EVENT ON 07-APRIL-2026 AND TREATED WITH INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595915 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-242A 6014575 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown