BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 8844050 · Received July 30, 2019

    Report

    Report Number
    3005099803-2019-03734
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729772880
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EVENT DATE WAS APPROXIMATED TO (B)(6) 2019 AS THE EVENT REPORTEDLY OCCURRED IN (B)(6) 2019. HOWEVER, THE SPECIFIC EVENT DATE IS UNKNOWN. IMPLANT DATE: THE IMPLANT DATE WAS APPROXIMATED TO (B)(6) 2019 AS THE DEVICE WAS IMPLANTED IN (B)(6) 2019. HOWEVER, THE SPECIFIC IMPLANT DATE IS UNKNOWN. (B)(4). THE VOLUNTARY USER MEDWATCH NUMBER IS (B)(4). THE COMPLAINT DEVICE 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 WAS IMPLANTED DURING URETHROPEXY USING VAGINAL TAPE REPAIR AND CYSTOCELE WITH BIOLOGIC GRAFT CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS DISCHARGED ON THE SAME DAY OF HER SURGERY. IN (B)(6) 2019, SHE BEGAN TO EXPERIENCE INCREASING LOWER ABDOMINAL PAIN AND WAS ALSO TREATED WITH ANTIBIOTICS FOR A URINARY TRACT INFECTION (UTI). FURTHERMORE, THE PATIENT THEN BEGAN TO EXPERIENCE ITCHING HANDS, VAGINAL ITCHING, AND QUESTIONED IF SHE POSSIBLY WAS ALLERGIC TO THE VAGINAL SLING. THE MEDICATIONS WERE STOPPED AND THE PATIENT WAS GIVEN WITH BENADRYL TO SEE IF ITCHING IMPROVED. ITCHING CONTINUED AND SHE WAS PLACED ON PREDNISONE. HOWEVER, ITCHING PERSISTED AND WAS THEN GIVEN WITH ATARAX. THE PATIENT QUESTIONED AGAIN IF SHE WAS EXPERIENCING AN ALLERGIC REACTION TO THE SLING. A MEDROL DOSEPAK WAS ADMINISTERED ALONG WITH VISTARIL WITH NO RELIEF. THE PATIENT WAS THEN SEEN BY AN ALLERGIST AND APPROXIMATELY FIFTY-ONE DAYS AFTER SLING PLACEMENT, THE SLING WAS SURGICALLY REMOVED AND THE PATIENT HAD EXPERIENCED NO FURTHER ITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637231 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502110 0023182541 08714729772880

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention