BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILIMED VAGINAL STENT

    MDR report key: 1069987 · Received July 2, 2008

    Report

    Report Number
    1651189-2008-00001
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 2, 2008
    Manufacturer
    SIENTRA, INC
    Product Code
    KXP
    PMA / PMN Number
    K974479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT SUFFERED FROM VAGINAL AGENESIS. THE VAGINAL STENT (PRODUCT NUMBER 3521-095) WAS INSERTED IN THE OPERATING ROOM DURING THE CREATION OF A NEOVAGINAL CAVITY ON (B) (6) 2008. THE DAY AFTER THE SURGERY, THE STENT FELL OUT. THE STENT WAS INSERTED BACK IN PLACE AND IT FELL OUT ONCE AGAIN. UPON INSPECTION, IT APPEARED THAT THE STENT WAS NO LONGER INFLATED TO THE LEVEL IT WAS WHEN IT WAS PLACED INTO THE VAGINAL CANAL. THE STENT WAS INFLATED OUTSIDE OF THE PT'S BODY AND IT STAYED INFLATED. IT WAS INSPECTED AND NO HOLES WERE FOUND. THE STENT WAS ONCE AGAIN INSERTED IN THE PT AND ONCE AGAIN, IT CAME OUT. UPON INSPECTION IT WAS NOTED THAT THE STENT HAD DEFLATED. THE PT UNDERWENT A SECOND SURGERY ON (B) (6), 2008 AND AN ALTERNATIVE DEVICE WAS USED TO REPLACE THE VAGINAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILIMED VAGINAL STENT KXP SIENTRA, INC 3521

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other