BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY GEL SILTEX ROUND MODERATE PLUS PROFILE MAMMARY PROSTHESIS

    MDR report key: 5846884 · Received August 4, 2016

    Report

    Report Number
    1645337-2016-00117
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    June 10, 2016
    Report Date
    August 3, 2016
    Manufacturer
    MENTOR WW LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALCL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498552 MEMORY GEL SILTEX ROUND MODERATE PLUS PROFILE MAMMARY PROSTHESIS BREAST IMPLANT FTR MENTOR WW LLC 5933012

    Patients

    Seq Age Sex Outcome Treatment
    0 Other