BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE

    MDR report key: 4151074 · Received September 19, 2014

    Report

    Report Number
    4151074
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 25, 2014
    Report Date
    August 22, 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

    RUPTURE OF LEFT BREAST SALINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584437 NATRELLE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN 68HP 800CC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NOT APPLICABLE.