BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 25054523 · Received May 1, 2026

    Report

    Report Number
    3003442380-2026-13372
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 4, 2026
    Report Date
    April 7, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: NAME: YPSOMED AG. STREET: WEISSENSTEINSTRASSE 26. CITY: SOLOTHURN. COUNTRY: SWITZERLAND. POSTAL 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: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA CAUSING AN OCCLUSION, WHICH LED TO HYPERGLYCEMIA ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115340 INSET II SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 86-060-52B6 6004937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown