BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE SILICONE-FILLED BREAST IMPLANTS

    MDR report key: 10401032 · Received August 13, 2020

    Report

    Report Number
    10401032
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 3, 2020
    Manufacturer
    ALLERGAN, INC.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MIDDLE AGED PATIENT WITH BREAST CANCER WITH RUPTURE LEFT BREAST IMPLANT. SHE UNDERWENT PROCEDURE FOR REMOVAL. PER PATHOLOGY REPORT: LEFT BREAST IMPLANT 322CC DISRUPTED IMPLANT MEASURING 13.5X 13.5X 3.5CM. MANUFACTURER IS ALLERGAN 320ML WITH LOT NUMBER 2070674. RIGHT BREAST IMPLANT 180CC RECEIVED FRESH IS A BREAST IMPLANT MEASURING 12.0X 12.0X 2.5CM. THE MANUFACTURER NAME IS ALLERGAN 180ML, LOT NUMBER 2048622.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866633 NATRELLE SILICONE-FILLED BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN, INC. 115-322 2070674 2048622

    Patients

    Seq Age Sex Outcome Treatment
    1 14600 DA