BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR - SILTEX

    MDR report key: 490192 · Received October 8, 2003

    Report

    Report Number
    MW1029769
    Event Type
    Malfunction
    Date Received
    October 8, 2003
    Report Date
    September 29, 2003
    Manufacturer
    MENTOR HS, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1997 - BIL BREAST AUGMENTATION WITH MENTOR SALINE IMPLANTS. IN 2003 - DEFLATION RIGHT BREAST IMPLANT. IN 2003 - PT. UNDERWENT BIL CAPSULECTOMY AND IMPLANT REMOVAL. AUGMENTED WITH MENTOR SALINE IMPLANTS BIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR - SILTEX SALINE MAMMARY IMPLANT FWM MENTOR HS, INC. * 151019

    Patients

    Seq Age Sex Outcome Treatment
    1 *