BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 12926885 · Received December 3, 2021

    Report

    Report Number
    3005099803-2021-06576
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 10, 2021
    Report Date
    January 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: A PREVIOUS REPORT FOR THIS PATIENT AND DEVICE HAS BEEN SENT UNDER MFR REPORT # 3005099803-2020-06766. BLOCK A1: MESHC-20211028-D3CDB8A7 BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE.BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; 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.

    Additional Manufacturer Narrative · 0

    (B)(6) THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; 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 · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANTAGE FIT IMPLANT WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PAIN INTER; DIFF BOWEL; INCONT NOT PRES; REC INCONT; OTH PAIN: CONSTANT PAIN WHERE THE MESH WAS IMPLANTED, CANT SIT CROSS LEGGED, OR SIT IN A SEATED POSITION FOR TO LONG.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANTAGE FIT IMPLANT WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PAIN INTER; DIFF BOWEL; INCONT NOT PRES; REC INCONT; OTH PAIN: CONSTANT PAIN WHERE THE MESH WAS IMPLANTED, CANT SIT CROSS LEGGED, OR SIT IN A SEATED POSITION FOR TO LONG

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824600 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION 850-211

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention