BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY IMPLANT

    MDR report key: 154082 · Received March 3, 1998

    Report

    Report Number
    1816403-1998-00110
    Event Type
    Injury
    Date Received
    March 3, 1998
    Date of Event
    January 5, 1998
    Report Date
    January 19, 1998
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF BILATERAL BREAST IMPLANTS; MASTODYNIA AND BREAST CAPSULES, PAINFUL, SCAR FORMATION. BOTH IMPLANTS WERE INTACT; BOTH INSCRIBED "DOW CORNING WRIGHT 325CC"

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other