BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUID INJECTABLE SILICONE

    MDR report key: 1227035 · Received November 11, 2008

    Report

    Report Number
    MW5008957
    Event Type
    Injury
    Date Received
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    NA
    Product Code
    KGM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD "MEDICAL GRADE" LIQUID INJECTABLE SILICONE INJECTED BY A NYC DERMATOLOGIST FOR IMPROVEMENT OF WRINKLES INTO GLABELLA AND NASOLABIAL FOLDS 15 YEARS AGO. HAS NOW DEVELOPED NODULES WHICH HAVE BEEN BIOPSIED AND DIAGNOSED AS SILICONE GRANULOMAS. LARGEST HAS BEEN 5CM IN DIAMETER. THEY WAX AND WANE IN THEIR SIZE, ARE PAINFUL AND ARE DISFIGURING. DOSE OR AMOUNG: ?; FREQUENCY: TWICE; ROUTE: ID. DATES OF USE: 2 MOS; DIAGNOSIS OR REASON FOR USE: WRINKLE CORRECTION;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUID INJECTABLE SILICONE KGM NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability