BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

    MDR report key: 12188896 · Received July 19, 2021

    Report

    Report Number
    3005099803-2021-03590
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    October 2, 2016
    Report Date
    July 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE DEVICE WAS 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 A BSC DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT STARTED TO EXPERIENCE URINARY INCONTINENCE, URINARY URGENCY, CONSTIPATION AND NUMBNESS. IN MAY 2019, THE PATIENT EXPERIENCED PAIN IN THE PELVIS AND "STRIP PREVENTS THE URETHRA MUSCLE FROM DOING ITS JOB OF CHECKING URINE" (TISSUE DAMAGE) AND HAD TO WEAR PROTECTION UNDERNEATH SINCE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086106 MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other