BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 284330 · Received June 30, 2000

    Report

    Report Number
    284330
    Event Type
    Malfunction
    Date Received
    June 30, 2000
    Date of Event
    May 10, 2000
    Report Date
    June 26, 2000
    Manufacturer
    UNK
    Product Code
    KGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BREAST INJECTED WITH SILICONE IN 1990. REMOVED HARDENED SILICONE AND REPLACED WITH IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INJECTABLE SILICONE BREAST IMPLANT KGM UNK UNK UNK
    2 * ---

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other