BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX CONTOUR PROFILE

    MDR report key: 106941 · Received July 18, 1997

    Report

    Report Number
    1645337-1997-00093
    Event Type
    Injury
    Date Received
    July 18, 1997
    Date of Event
    March 29, 1997
    Report Date
    July 11, 1997
    Manufacturer
    MENTOR H/S
    Product Code
    LCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SILTEX CONTOUR PROSTHESIS ON 3/24/97. SUBSEQUENTLY, IT WAS NOTED THAT THE PT HAD DEVELOPED AN INFECTION AND THE PROSTHESIS WAS REMOVED. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO NEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, FEBRUARY 10, 1992). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21CFR803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX CONTOUR PROFILE Implant TISSUE EXPANDER LCJ MENTOR H/S NA 127726

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention