BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX? SIS SYSTEM

    MDR report key: 22935056 · Received September 2, 2025

    Report

    Report Number
    2124215-2025-60920
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 21, 2025
    Report Date
    September 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729774044
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040609 CAPTURES THE REPORTABLE CODE OF SHAFT TIP BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE USING A SOLYX? SIS SYSTEM DEVICE, THE NEEDLE TIP BECAME BENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SOLYX? SIS SYSTEM DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248125 SOLYX? SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507000 0032849220 08714729774044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female