BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3193121 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-05028
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDVENTURE TECHNOLOGY CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED ON (B)(6) 2011. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2011, THE IMPLANTING PHYSICIAN COULD SEE SOME OF THE MESH ERODING THROUGH THE SUTURE LINE. DURING AN EXAMINATION ON (B)(6) 2011, THE MESH COULD STILL BE SEEN ERODING THROUGH THE SUTURE LINE. IN (B)(6) 2011, THE PATIENT¿S PROLAPSE REOCCURRED, AND IT LOOKED AS IF THE UPHOLD MESH WAS BUNCHED NEAR THE CERVIX. ON (B)(6) 2012, ANOTHER PHYSICIAN REMOVED THE UPHOLD DEVICE FROM THE PATIENT, PERFORMED A HYSTERECTOMY AND A PROLAPSE REPAIR, AND IMPLANTED A PINNACLE POSTERIOR PFR KIT AND AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293508 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL MEDVENTURE TECHNOLOGY CORPORATION M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention