BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 253639 · Received December 6, 1999

    Report

    Report Number
    253639
    Event Type
    Other
    Date Received
    December 6, 1999
    Date of Event
    December 3, 1999
    Report Date
    December 3, 1999
    Manufacturer
    MENTOR H/S INC.
    Product Code
    FTR
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NO PROBLEM WITH DEVICE. REVISION OF BREAST RECONSTRUCTION TO CORRECT SIZE DIFFERENCE. ASSYMETRY GEL MENTOR IMPLANT. BECKER REMOVED PREVIOUS DATE. GEL IMPLANT REMOVED & REPLACED WITH DIFFERENT GEL TO CORRECT ASSYMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant MAMMARY PROSTHESIS/EXPANDER FTR MENTOR H/S INC. 354-3257 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other