BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 379360 · Received February 23, 2002

    Report

    Report Number
    MW1024218
    Event Type
    Other
    Date Received
    February 23, 2002
    Date of Event
    January 4, 2002
    Report Date
    February 23, 2002
    Manufacturer
    *
    Product Code
    KGM
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WENT TO SEE DERMATOLOGIST. HE INJECTED SILICONE IN REPORTER'S NOSE AND LIP AREA. THE NOSE IS NOW BUMPY AND FORMING GRANULOMA TISSUE ON THE SURFACE. THE INJECTION ON ONE SURFACE OF THE NOSE WAS TOO SUPERFICIAL. THE REPORTER WAS TOLD BY THE DOCTOR THAT SILICONE INJECTIONS WERE VERY SAFE. HE DID NOT TELL THE REPORTER THAT THIS IS NOT APROVED BY THE FDA. REPORTER WISH THEY COULD REVERSE THIS BUT IT'S TOO LATE NOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other