BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 221479 · Received April 23, 1999

    Report

    Report Number
    MW1016230
    Event Type
    Malfunction
    Date Received
    April 23, 1999
    Date of Event
    January 1, 1963
    Manufacturer
    UNK
    Product Code
    KGM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SILICONE HARDENED AND CAUSED MUCH PAIN, ALSO PIECES HAVE MOVED FROM BREAST TO OTHER PLACES, AS IF BROKEN AWAY. I'M UNABLE TO HAVE MAMMOGRAMS. ULTRASOUND HASN'T WORKED EITHER. NO WAY TO DETERMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SILICONE INJECTIONS KGM UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other