BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLASTY

    MDR report key: 1113063 · Received July 31, 2008

    Report

    Report Number
    1113063
    Event Type
    Malfunction
    Date Received
    July 31, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BRENNAN MEDICAL, INC.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    RIGHT SILICONE GEL BREAST IMPLANT RUPTURED. PATIENT DESIRED BOTH SILICONE GEL IMPLANTS TO BE REMOVED AND TO HAVE A BILATERAL BREAST LIFT. LEFT BREAST IMPLANT WAS INTACT UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLASTY BREAST IMPLANT, SILICONE FTR BRENNAN MEDICAL, INC. 90F18-3-052811S *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR