BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2810711 · Received October 31, 2012

    Report

    Report Number
    3005099803-2012-05087
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN UPHOLD VAGINAL SUPPORT SYSTEM DURING A PROLAPSE REPAIR PROCEDURE (DATE UNKNOWN) THAT WENT FINE. DURING A FOLLOW-UP APPOINTMENT (DATE UNKNOWN), AS THE PHYSICIAN WAS EXAMINING THE PATIENT, HE PALPATED 1MM OF MESH EXTRUSION THROUGH THE VAGINA. REPORTEDLY, NO MEDICAL INTERVENTION IS REQUIRED BECAUSE THE PATIENT IS ASYMPTOMATIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other