BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 25256259 · Received May 22, 2026

    Report

    Report Number
    8021545-2026-09275
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 24, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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: 802154.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE TAPE DID NOT STICK AND INFUSION SET FELL OFF DUR TO SWEATING ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481017 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-431A UNKNOWN 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1