BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2771223 · Received October 3, 2012

    Report

    Report Number
    3005099803-2012-04409
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE THIRD OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2012-04404 AND 3005099803-2012-04408 FOR A DESCRIPTION OF THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URGENCY, URINE LEAKAGE, RECURRENT URINARY TRACT INFECTIONS, BLADDER PAIN, DYSURIA, LEG PAIN, ABDOMINAL AND PELVIC PAIN. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 0ML9122801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SOLYX SINGLE INCISION SLING SYSTEM| PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT