BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24872845 · Received April 14, 2026

    Report

    Report Number
    3003442380-2026-83955
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 16, 2026
    Report Date
    March 17, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 PATIENT HAS ISSUE WITH INFUSION SET TAPE IS NOT STICKING ON INSERTION SITE ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316265 INSET II Set, administration, intravascular FPA UNOMEDICAL A/S 86-060-52B6 6010630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown