BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX LOW BLEED GEL-FILLED MAMMARY IMPLANT

    MDR report key: 167911 · Received May 14, 1998

    Report

    Report Number
    1645337-1998-00013
    Event Type
    Injury
    Date Received
    May 14, 1998
    Report Date
    August 29, 1997
    Manufacturer
    MENTOR
    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 WITH SILTEX LOW BLEED GEL DEVICES ON 8/10/1994, SUBSEQUENTLY THE PT EXPERIENCED INFECTION, DELAYED WOUND HEALING, BREAST PAIN, RHEUMATOID ARTHRITIS, CHRONIC FATIGUE AND ABNORMAL BRUISING AND BLEEDING. THE PROSTHESIS WERE REMOVED IN 1995.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX LOW BLEED GEL-FILLED MAMMARY IMPLANT Implant MAMMARY PROSTHESIS FTR MENTOR NA 80369 / 76843

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention