BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 25309998 · Received May 27, 2026

    Report

    Report Number
    3003442380-2026-23094
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL 2 OF 2. NAME: YPSOMED AG, COUNTRY: CZECH REPUBLIC, STREET: WEISSENSTEINSTRASSE 26, CITY: SOLOTHURN, ZIP CODE: CH-4503. 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 FACED OCCLUSION AT INSERTION SITE ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294940 INSET II Set, administration, intravascular FPA UNOMEDICAL DEVICES S.A DE C.V 86-060-52B6 6013910

    Patients

    Seq Age Sex Outcome Treatment
    1