BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC (R) MAMMARY IMPLANT

    MDR report key: 46502 · Received October 30, 1996

    Report

    Report Number
    1816403-1996-00206
    Event Type
    Injury
    Date Received
    October 30, 1996
    Date of Event
    January 1, 1990
    Report Date
    September 30, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES RECEIVING BREAST IMPLANTS ON 8/15/83. PT ALSO ALLEGES BETWEEN 1990 AND 1995 SHE HAD ANEMIA AND INJECTIONS, ALLERGIES AND HYPERSENSITIVITY TO MERCURY AND AMALGAM. IN 1/1994 SHE DEVELOPED CLINICAL DEPRESSION AND INSOMNIA. PT ALSO ALLEGES HER LEFT PROSTHESIS RUPTURED AND HER LEFT BREAST DIMINISHED IN 12/1994; THEREFORE, SHE HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON 1/26/95 WITH SALINE DEVICES OF ANOTHER MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC (R) MAMMARY IMPLANT Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R