BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE

    MDR report key: 4251833 · Received October 10, 2014

    Report

    Report Number
    4251833
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 20, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT STATUS POST BILATERAL BREAST AUGMENTATION WITH SALINE IMPLANTS; LEFT BREAST IMPLANT DEFLATION.IT WAS NOTED TO BE ALMOST COMPLETELY DEFLATED. ON COMPRESSING THE IMPLANT, A SMALL HOLE WAS NOTED IN THE ANTERIOR WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640815 NATRELLE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN 68MP *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR