BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 1192188 · Received October 8, 2008

    Report

    Report Number
    MW5008573
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    February 28, 2008
    Report Date
    October 1, 2008
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAKAGE FROM GEL IMPLANT AND GRANULOMA ON RIGHT BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BREAST IMPLANT, SILICONE GEL FTR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR