BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX LOW BLEED GEL

    MDR report key: 106932 · Received July 18, 1997

    Report

    Report Number
    1645337-1997-00094
    Event Type
    Injury
    Date Received
    July 18, 1997
    Date of Event
    February 10, 1994
    Report Date
    July 17, 1997
    Manufacturer
    MENTOR H/S
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BILATERALLY IMPLANTED SILTEX LOW BLEED GELS ON 1/20/94. SUBSEQUENTLY, IT WAS NOTED THAT THE PT HAD DEVELOPED A SEROMA IN HER LEFT BREAST AND CAPSULAR CONTRACTURE IN BOTH BREASTS. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVAL PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE. 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 LOW BLEED GEL Implant MAMMARY PROSTHESIS FTR MENTOR H/S NA 61116/61398

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention