BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE SILICONE-FILLED FULL PROFILE STYLE 45 BREAST IMPLAN

    MDR report key: 2020758 · Received March 7, 2011

    Report

    Report Number
    2020758
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ALLERGEN
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT BREAST IMPLANT RUPTURED UPON REINSERTION. PHYSICIAN INSERTED IT INITIALLY WITHOUT INCIDENT, TOOK IT OUT TO SUTURE AN AREA OF THE BREAST, THEN RE-INSERTED THE IMPLANT. IT RUPTURED AT THIS POINT. PER THE PHYSICIAN, NO UNUSUAL FORCE OR USE OF THE IMPLANT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATRELLE SILICONE-FILLED FULL PROFILE STYLE 45 BREAST IMPLAN BREAST IMPLANT FTR ALLERGEN 45-280 L072-03 OR 2032011 (NOT SURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO OTHER THERAPIES