BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR HIGH PROFILE 375CC SIZER

    MDR report key: 8132654 · Received December 5, 2018

    Report

    Report Number
    8132654
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 13, 2018
    Report Date
    November 27, 2018
    Manufacturer
    MENTOR TEXAS, LP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING BREAST AUGMENTATION SURGERY, WHILE HANDLING 1ST STERILE SIZER IT RUPTURED OUTSIDE OF THE PATIENT. NO IMPACT TO PATIENT. PROCEEDED TO OPEN 2ND SIZER, WAS PLACED INTO THE PATIENT'S BREAST POCKET, WHERE IT RUPTURED IN PATIENT'S LEFT SIDE. SIZER WAS REMOVED, POCKET WAS PROFUSELY IRRIGATED WITH ANTIBIOTIC SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971759 MENTOR HIGH PROFILE 375CC SIZER PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS, LP RSZ-3754

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA