BEUDAMED
    FDA Adverse Event Other Summary report: N

    GFX-LP

    MDR report key: 2423784 · Received January 14, 2012

    Report

    Report Number
    MW5023869
    Event Type
    Other
    Date Received
    January 14, 2012
    Date of Event
    April 11, 2005
    Report Date
    January 14, 2012
    Manufacturer
    NAGOR LTD.
    Product Code
    NXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BILATERAL BREAST AUGMENTATION 1998. IN 2000, PATIENT NOTED DIFFERENCE IN RIGHT BREAST, MAMMOGRAM TEST AND ULTRASOUND SUGGESTED NO PROBLEM. IN 2003, PATIENT STILL CONCERNED ABOUT RIGHT BREAST, MAMMOGRAM AND ULTRASOUND REPEATED, AGAIN SUGGESTED NO PROBLEM. IN 2004, PATIENT REFERRED BACK TO IMPLANTING SURGEON, FOLLOWING ULTRASOUND, CONFIRMATION OF RUPTURED COHESIVE GEL SILICONE IMPLANT. ON EXPLANTATION IMPLANT SHELL IN TWO PIECES, FILLING COMPLETELY DETACHED FROM OUTER SHELL. [EVENT REAPPEARED AFTER REINTRODUCTION: YES].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GFX-LP COHESIVE GEL NXH NAGOR LTD. GFX-LP S3316/1
    2 GFX-LP COHESIVE GEL NXH NAGOR LTD. GFX-LP S3316/1

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other