BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANTS

    MDR report key: 70609 · Received February 21, 1997

    Report

    Report Number
    MW1010781
    Event Type
    Injury
    Date Received
    February 21, 1997
    Date of Event
    August 14, 1990
    Report Date
    February 6, 1997
    Manufacturer
    3-M CO.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    BORN TO MOTHER WITH SILICONE BREAST IMPLANTS THAT LEAKED. SILICONE CROSSES THE PLACENTA. BREAST FED FOR 6 MONTHS. SILICONE CONTAINED IN BREAST MILK. ARTHRITIS, LUPUS, RASHES, ESOPHAGEAL MOBILITY PROBLEMS, AND URINARY TRACT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE BREAST IMPLANTS Implant SILICONE BREAST IMPLANTS FTR 3-M CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Disability