BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE STYLE 133 SERIES

    MDR report key: 3735273 · Received April 1, 2014

    Report

    Report Number
    3735273
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    August 6, 2013
    Report Date
    April 1, 2014
    Manufacturer
    ALLERGAN INC.
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A BILATERAL MASTECTOMY WITH PLACEMENT OF TISSUE EXPANDERS. DUE TO COMPLICATIONS FROM INFECTION, THE EXPANDERS WERE REMOVED WITHIN ONE MONTH OF PLACEMENT. THE LEFT BREAST WAS CLOSED WITH A DRAIN PLACED; THE RIGHT BREAST WAS LEFT OPEN WITH A WOUND VAC PLACED AND SUBSEQUENTLY CLOSED.THE PATIENT RETURNED FOR TISSUE EXPANDER PLACEMENT AND CONTINUED RECONSTRUCTION AFTER BEING TREATED FOR THE PREVIOUS INFECTION. DURING THE SURGERY A TAB FROM THE PREVIOUS EXPANDER WAS DISCOVERED IN THE LEFT BREAST POCKET AND REMOVED WITHOUT COMPLICATION. THE TAB SEPARATED FROM THE EXPANDER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER EVENT. THE TAB IS NOT RADIOPAQUE AND IS NOT VISIBLE ON RADIOGRAPHIC IMAGING IF SEPARATED FROM THE TISSUE EXPANDER.MANUFACTURER RESPONSE FOR TISSUE EXPANDER, ALLERGAN INC. NATRELLE-EXPANDER MOD TAB 700CC (PER SITE REPORTER).====================== NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196098 NATRELLE STYLE 133 SERIES EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN INC. * 1787668

    Patients

    Seq Age Sex Outcome Treatment
    1 *