BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILCONE BREAST IMPLANTS

    MDR report key: 998057 · Received February 11, 2008

    Report

    Report Number
    MW5005425
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    April 16, 2007
    Report Date
    February 11, 2008
    Manufacturer
    SCL
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL REMOVE AND REPLACE SILICONE BREAST IMPLANTS, RIGHT CAPSULOTOMY, INTACT IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILCONE BREAST IMPLANTS FTR SCL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR