BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX BLUE

    MDR report key: 21626323 · Received March 17, 2025

    Report

    Report Number
    2124215-2025-15882
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729961901
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT, AS NO EVENT DATE WAS REPORTED. 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 MID-URETHRAL SLING PROCEDURE USING A SOLYX BLUE DEVICE, THE NEEDLE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567002 SOLYX BLUE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507010 0035571940 08714729961901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown