BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX BLUE

    MDR report key: 24052588 · Received January 13, 2026

    Report

    Report Number
    2124215-2026-02081
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    November 5, 2025
    Report Date
    January 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729961901
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULTY ADVANCING THE DEVICE THROUGH THE PATIENT'S TISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SOLYX DEVICE WAS DIFFICULT TO ADVANCE THROUGH THE PATIENT'S TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118166 SOLYX BLUE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507010 0036774955 08714729961901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female