BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2800311 · Received October 22, 2012

    Report

    Report Number
    3005099803-2012-04758
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 AN UNKNOWN DATE. A SOLYX SINGLE INCISION SLING SYSTEM WAS ALSO IMPLANTED. THE IMPLANTATION DATES PROVIDED ARE (B)(6) 2009, BUT IT WAS NOT SPECIFIED WHICH DEVICE/S WERE IMPLANTED ON EACH DATE. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED ANTERIOR ENTEROCELE AND POSTERIOR VAGINAL VAULT PROLAPSE, CAUSING SEVERE PERSISTENT PAIN AND DIFFICULTY URINATING. ALL OTHER INFORMATION IS UNKNOWN.

    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