BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 24843449 · Received April 10, 2026

    Report

    Report Number
    8021545-2026-88526
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 12, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: EVENT CITY: (B)(6) EVENT COUNTRY: IRELAND NAME: MEDTRONIC MINIMED COUNTRY: (B)(6) STREET: (B)(6) CITY: (B)(6) STATE: (B)(6) ZIP CODE: (B)(6) 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 THE PATIENT HAD HYPERGLYCEMIA AND TREATED WITH INSULIN PEN INJECTIONS ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904310 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-431A 6009113 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown