BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE TISSUE EXPANDER

    MDR report key: 3082025 · Received April 15, 2013

    Report

    Report Number
    3082025
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    BREAST TISSUE EXPANDER LEAKED AND HAD TO BE REPLACED. TISSUE EXPANDER LEAKED NORMAL SALINE TINTED WITH METHYLANE BLUE INTO LEFT BREAST CAVITY. TISSUE EXPANDER WAS REMOVED AND SENT TO PATHOLOGY FOR GROSS STUDY ONLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IMPLANT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160958 NATRELLE TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN 133FX-14 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR