BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2072229 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01455
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WHEN AN UPHOLD VAGINAL SUPPORT SYSTEM KIT WAS OPENED AND EXAMINED DURING AN ANTERIOR REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SLEEVE OF ONE OF THE LEG ASSEMBLIES WAS NOT COMPLETELY COVERING THE MESH LEG. PER THE PHYSICIAN, THE SLEEVE APPEARED TO BE HELD IN PLACE, JUST NOT ALL THE WAY; IT SEEMED TO BE PARTIALLY PULLED OFF. IT IS UNKNOWN WHETHER THE TACK WELD WAS INTACT. THE PHYSICIAN DECIDED TO PROCEED WITH THE IMPLANTATION PROCEDURE USING THIS DEVICE. AS THE PHYSICIAN ATTEMPTED TO PULL THE AFFECTED LEG ASSEMBLY THROUGH THE LEFT SACROSPINOUS LIGAMENT, THE SLEEVE PULLED COMPLETELY OFF FROM THE MESH AND FELL LOOSE INTO THE PATIENT. THE SLEEVE WAS RETRIEVED FROM INSIDE THE PATIENT WITH A PAIR OF PICK-UPS, AND WAS NOTED TO BE COMPLETELY INTACT. THE PHYSICIAN COMPLETED THE PROCEDURE USING ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML1022205

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention