BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPSYLON?

    MDR report key: 3143460 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04489
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTO
    PMA / PMN Number
    K122794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED DURING A ROBOTIC SACRAL COLPOPEXY WITH HYSTERECTOMY PROCEDURE. DURING THE PROCEDURE, WHEN THE PHYSICIAN PLACED THE SUTURE THROUGH THE MESH INSIDE THE SACRUM, THE MESH TORE. THE PHYSICIAN FELT THE TEAR WAS TOO SMALL TO BE OF CONCERN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS OVER 18 YEARS OF AGE AND WAS FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245385 UPSYLON? MESH, SURGICAL, SYNTHETIC OTO BOSTON SCIENTIFIC - MARLBOROUGH M0068318200

    Patients

    Seq Age Sex Outcome Treatment
    1