BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILTEX CONTOUR EXPANDER W/ INTEGRAL INJ. SITE

    MDR report key: 953608 · Received October 10, 2007

    Report

    Report Number
    1645337-2007-00013
    Event Type
    Other
    Date Received
    October 10, 2007
    Report Date
    October 9, 2007
    Manufacturer
    MENTOR
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PER VOLUNTARY REPORT, "LEFT BREAST TISSUE EXPANDER INTRAOPERATIVELY FILLED TO 420 CC A FEW MONTHS AGO REQUIRED EXPLANTATION WITH RE-INSERTION FIFTY-FOUR DAYS LATER WITH NEW EXPANDER. CULTURE AND SENSITIVITY OF SEROMA FLUID PENDING." THE DEVICE WAS NOT RETURNED TO MENTOR FOR EVAL. A REVIEW OF THE MENTOR COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS AGAINST THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX CONTOUR EXPANDER W/ INTEGRAL INJ. SITE TISSUE EXPANDER LCJ MENTOR * 5727244

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other