BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT ULTRA SYSTEM

    MDR report key: 24028400 · Received January 9, 2026

    Report

    Report Number
    2124215-2026-01709
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    00191506007669
    PMA / PMN Number
    K211223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: THE PREMARKET / 510(K) #S ARE K211223 & K231549. BLOCK H6: DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF SEAL COMPROMISED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION, THE PACKAGING SEAL WAS COMPROMISED DUE TO AN INCOMPLETELY GLUED EDGE. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91443 ADVANTAGE FIT ULTRA SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET OTN BOSTON SCIENTIFIC CORPORATION M0068502160 0037058543 00191506007669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown