BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE 410

    MDR report key: 6943807 · Received October 12, 2017

    Report

    Report Number
    MW5072721
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY PLASTIC SURGEON INSTALLED AN ALLERGAN NATRELLE 410 TEAR SHAPE BREAST IMPLANT. THE DEVICE WAS OUTLAWED FOR MANY YEARS. THE TEXTURED BACKING IS ADHERING TO MY CHEST WALL CAUSING ME A GREAT DEAL OF PAIN BECAUSE OF THE RIPPING FROM THE WALL IS ADHERED TO. I HAVE ASKED MY PLASTIC SURGEON TO IMMEDIATELY REMOVE THIS INFERIOR PRODUCT AT ONCE. BUT SINCE MY PS IS CONCERNED WITH WOUND ISSUES, I WILL BE FORCED TO SUFFER UNTIL THEIR REMOVAL. I SINCERELY THINK THIS PRODUCT HAS NO BUSINESS BEING ALLOWED TO BE INSTALLED IN ANYONE AND THE FDA HAS A RESPONSIBILITY TO PROTECT THE PUBLIC AND REMOVE THEM FROM THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722838 NATRELLE 410 BREAST IMPLANT FTR ALLERGAN MX-410685

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention