BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 13937883 · Received March 29, 2022

    Report

    Report Number
    13937883
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 18, 2022
    Report Date
    March 25, 2022
    Manufacturer
    MENTOR TEXAS, LP
    Product Code
    MRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BILATERAL BREAST IMPLANT REMOVAL DUE TO BREAST ASYMMETRY. PATHOLOGY REPORT: LEFT BREAST RECEIVED IN FORMALIN A 71G 13.0X 12.0 X 1.0CM PREVIOUSLY DISRUPTED IMPLANT. THE WALL DISPLAYS INSCRIPTION MENTOR, CM350CC. A 0.5CM SLIT-LIKE DEFECT IS IDENTIFIED IN THE WALL WITH OVERLYING TAN FIBROUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729500 MENTOR SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS, LP CM350CC

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA Female