BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24934740 · Received April 21, 2026

    Report

    Report Number
    3003442380-2026-08270
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 26, 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

    MDR 3003442380-2026-08270 / 1 OF 2. NAME: YPSOMED AG, COUNTRY: SWITZERLAND, STREET: WEISSENSTEINSTRASSE 26, CITY: SOLOTHURN, ZIP CODE: 92121. 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 AN EVENT IN WHICH 10 SETS FELL OFF IMMEDIATELY UPON INSERTION ON 25 MAR 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235107 INSET II SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 86-060-52B6 6014401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown