BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2091973 · Received May 18, 2011

    Report

    Report Number
    3005099803-2011-01590
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS A LEG ASSEMBLY WAS BEING THROUGH THE SACROSPINOUS LIGAMENT, APPROXIMATELY ONE CENTIMETER OF SUTURE (WITH THE NEEDLE AT THE END) DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE POST-PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0120601

    Patients

    Seq Age Sex Outcome Treatment
    1