BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT ULTRA SYSTEM

    MDR report key: 24888942 · Received April 15, 2026

    Report

    Report Number
    2124215-2026-20448
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    00191506007669
    PMA / PMN Number
    K211223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE EVENT DATE OF (B)(6) 2026, WAS SELECTED AS A BEST ESTIMATE, BASED ON THE REPORTED TIMEFRAME OF ONE WEEK POST-OPERATION FOLLOWING THE PROCEDURE ON (B)(6) 2026. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER, THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G4: THE PREMARKET / 510(K) #S ARE K211223 & K231549. BLOCK H6: THE FOLLOWING IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E2326 - INFLAMMATION . E2238 - SWELLING/EDEMA. E2008 - FOREIGN BODY IN PATIENT. IMDRF IMPACT CODE F2303 CAPTURE THE REPORTABLE EVENT OF ANTIBIOTIC PRESCRIPTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ADVANTAGE MESH SLING DEVICE WAS IMPLANTED IN THE PATIENT. APPROXIMATELY ONE WEEK AFTER THE PROCEDURE, THE PATIENT DEVELOPED SWELLING AND DISCOMFORT AT ONE OF THE ABDOMINAL SKIN INCISIONS, WHICH PROGRESSED INTO A LOCALIZED LUMP. THE PATIENT INDEPENDENTLY ATTEMPTED TO EXPRESS THE LUMP AND EXPELLED A PORTION OF A BLUE SUTURE CONSISTENT WITH THE LEADER LOOP FROM WITHIN THE INCISION. THE PHYSICIAN SUSPECTED THAT A RETAINED SEGMENT OF THE LEADER LOOP CONTRIBUTED TO THE PATIENT'S PAIN. MEDICATION WAS ADMINISTERED TO MANAGE THE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308183 ADVANTAGE FIT ULTRA SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET OTN BOSTON SCIENTIFIC CORPORATION M0068502160 00191506007669

    Patients

    Seq Age Sex Outcome Treatment
    1