BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 11340644 · Received February 17, 2021

    Report

    Report Number
    3005099803-2021-00552
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    July 19, 2017
    Report Date
    February 17, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729772880
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER EU GDPR (GENERAL DATA PROTECTION REGULATION), ONLY THE PATIENT'S WEIGHT, GENDER, AND AGE CAN BE REPORTED IN ANY REGULATORY REPORT. THUS, THE PATIENT'S INITIALS AND DATE OF BIRTH WILL NOT BE REPORTED. OTHER: ANSM ADVERSE INCIDENT REPORT REFERENCE NO (B)(4); SUBMITTED TO ANSM (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE) BY A HEALTHCARE PROFESSIONAL. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS IMPLANTED AND IS NOT EXPECTED TO BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, SINCE THE MESH IMPLANT, THE PATIENT HAS BEEN SUFFERING SEVERE PELVIC PAIN, NERVE DAMAGE (SCIATIC NERVE, ADDUCTOR NERVE, AND ISCHIUM), CHRONIC ACUTE SYMPHYSIS, NO LIBIDO AND SIGNIFICANT DECREASE IN LIFE. AS OF JANUARY 22, 2021, THERE WERE NO CHANGES SEEN IN THE PATIENT'S CONDITION AFTER MULTIPLE CONSULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236996 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502110 0000056093 08714729772880

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention