BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE FILLED - MENTOR

    MDR report key: 513183 · Received February 19, 2004

    Report

    Report Number
    MW1031231
    Event Type
    Injury
    Date Received
    February 19, 2004
    Report Date
    February 6, 2004
    Manufacturer
    MENTOR H/S, 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

    PT AUGMENTED 1996. APPROX 6 MOS AGO PT NOTICED DEFLATION LEFT BREAST IMPLANT. PE = DEFLATED LEFT BREAST IMPLANT - RIGHT BREAST IMPLANT INTACT WITH GRADE II PTOSIS AND GRADE 1 CAPSULAR CONTRACTURE. 2004 PT UNDERWENT BILATERAL REMOVAL OF BREAST IMPLANTS. AUGMENTED WITH MENTOR SALINE IMPLANTS - PT ALSO HAD BREAST LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE FILLED - MENTOR MAMMARY PROSTHESIS FWM MENTOR H/S, INC. * 124659
    2 SILTEX SALINE FILLED - MENTOR MAMMARY PROSTHESIS FWM MENTOR H/S, INC. * 124659

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention