BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILTEX CONTOUR EXPANDER W/INTEGRAL INJ. SITE

    MDR report key: 625801 · Received August 9, 2005

    Report

    Report Number
    1645337-2005-00005
    Event Type
    Death
    Date Received
    August 9, 2005
    Date of Event
    June 16, 2005
    Report Date
    July 15, 2005
    Manufacturer
    MENTOR
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT BILATERAL BREAST RECONSTRUCTION WITH MENTOR TISSUE EXPANDERS IN 2005. THEIR IMMEDIATE POSTOPERATIVE COURSE WAS COMPLICATED BY FEVER AND ATELECTASIS. PT WAS DISCHARGED ON PO DAY 3. SIX DAYS LATER, THEIR SKIN FLAPS WERE OBSERVED TO BE ECCYMOTIC WITH SUPERFICIAL EPIDERMOLYSIS. BASED ON THE MEDICAL RECORDS PROVIDED, THIS PT EXPIRED IN ABOUT A WEEK LATER FOLLOWING RAPID ONSET OF SEPSIS AND TOXIC SHOCK, WITH THE SURGICAL SITE AS POSSIBLE SOURCE. APPROX 24 HOURS PRECEDING DEATH, THE MASTECTOMY SKIN FLAPS HAD BEEN DEBRIBED AND EXPANDERS REMOVED. BASED ON THE OPERATIVE REPORT, NO GROSS PURULENCE WAS NOTED. FINAL WOUND CULTURES HAVE NOT BEEN FORWARDED TO MENTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX CONTOUR EXPANDER W/INTEGRAL INJ. SITE TISSUE EXPANDER LCJ MENTOR 354-6215 5585620

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death