BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 25329703 · Received May 29, 2026

    Report

    Report Number
    8021545-2026-10747
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 1, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: EVENT CITY: (B)(6). PATIENT COUNTRY: IRELAND. NAME: MEDTRONIC MINIMED STREET: 18000 DEVONSHIRE STREET CITY: NORTHRIDGE STATE: CA ZIP CODE: 91325. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. 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 EXPERIENCED INFUSION SET FELL OFF DUE TO TAPE NOT STICKING EVENT ON 30 APR 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580393 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-242A 6014095 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1