BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 25342121 · Received May 31, 2026

    Report

    Report Number
    8021545-2026-10735
    Event Type
    Malfunction
    Date Received
    May 31, 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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT 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 THE PATIENT FACED TAPE NOT STICKING EVENT ON (B)(6) 2026. THE PRODUCT DID NOT ADHERE DUE TO HOT WEATHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244172 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-242A 6014095 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1