BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2942580 · Received February 4, 2013

    Report

    Report Number
    3005099803-2013-00526
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN UPHOLD VAGINAL SUPPORT SYSTEM VIA A VERTICAL INCISION ON (B)(6) 2012. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CLINICALLY SIGNIFICANT BLEEDING FROM AN UNKNOWN CAUSE. THE BLEEDING WAS STOPPED WITH AN INJECTION OF THROMBIN AND THE PATIENT WAS IN "OKAY" CONDITION. SIX WEEKS LATER, THE PATIENT RETURNED, PRESENTING WITH DISCHARGE AND MESH EXTRUSION AT HER VAGINAL APEX. REPORTEDLY, THE PATIENT WAS SCHEDULED TO HAVE THE MESH REMOVED ON (B)(6) 2013 (SPECIFICS UNKNOWN). THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46610 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention