BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 154077 · Received March 3, 1998

    Report

    Report Number
    154077
    Event Type
    Injury
    Date Received
    March 3, 1998
    Date of Event
    January 5, 1998
    Report Date
    January 19, 1998
    Manufacturer
    DOW CORNING
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF BILATERAL BREAST IMPLANT; 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 NI Implant BREAST IMPLANTS FTR DOW CORNING UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention