BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 25010591 · Received April 27, 2026

    Report

    Report Number
    3003442380-2026-11580
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL 1 OF 2. NAME: YPSOMED AG. STREET: (B)(6). CITY: (B)(6). COUNTRY: SWITZERLAND. POSTAL CODE: (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: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370866 INSET II Set, administration, intravascular FPA UNOMEDICAL DEVICES S.A DE C.V 86-060-52B6 6015461

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown