BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX LOW BLEED GEL

    MDR report key: 98522 · Received June 11, 1997

    Report

    Report Number
    1645337-1997-00082
    Event Type
    Injury
    Date Received
    June 11, 1997
    Report Date
    June 5, 1997
    Manufacturer
    MENTOR H/S, INC.
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PURSUANT TO INFORMATION RECEIVED FROM THE PHYSICIAN, THE PATIENT WAS IMPLANTED WITH A SILTEX LOW BLEED GEL ON 06/06/96. SUBSEQUENTLY, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED A HEMATOMA IN HER RIGHT BREAST. 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, INC. NA 98526

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention