BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEL BREAST IMPLANTS

    MDR report key: 1210753 · Received October 20, 2008

    Report

    Report Number
    1210753
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 3, 2008
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO SURGEON WITH BILATERAL BREAST CONTRACTURE STATUS POST GEL BREAST AUGMENTATION. ADMITTED TO FACILITY FOR: BILATERAL CAPSULECTOMIES, REMOVAL OF RIGHT BREAST IMPLANT RUPTURED, REMOVAL OF LEFT INTACT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL BREAST IMPLANTS FTR

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other