BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE BLUE SYSTEM

    MDR report key: 16294642 · Received February 3, 2023

    Report

    Report Number
    3005099803-2023-00309
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    August 1, 2022
    Report Date
    February 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729961918
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: THE IMPLANTING HEALTHCARE FACILITY IS: (B)(6). DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022. REPORT SOURCE: ANSM USER REPORT (B)(4); SUBMITTED TO ANSM (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE) BY THE PATIENT. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE BLUE SYSTEM DEVICE WAS IMPLANTED IN A PROCEDURE ON (B)(6) 2022, FOR THE TREATMENT OF URINARY INCONTINENCE. ON (B)(6) 2022, THE PATIENT BEGAN TO EXPERIENCE VAGINAL PAIN AND CONSTANT URINARY TRACT INFECTION. THE PATIENT HAS BEEN TAKING ANTIBIOTICS FOR FOUR MONTHS AS PRESCRIBED BY THE PHYSICIAN. ADDITIONALLY, THE PATIENT IS UNABLE TO TRAVEL LONG DISTANCE BECAUSE SHE GOES TO THE TOILET FREQUENTLY. SHE ALSO OFTEN WAKES UP AT NIGHT TO GO TO THE BATHROOM. THE PATIENT CLAIMS TO BE PERMANENTLY ON ANTIBIOTICS BECAUSE HER UTI KEEPS RECURRING, BUT WHEN SHE TESTS HERSELF, THERE ARE NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082020 ADVANTAGE BLUE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502050 0028116610 08714729961918

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention