BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR SILTEX MAMMARY PROSTHESIS

    MDR report key: 1061855 · Received June 17, 2008

    Report

    Report Number
    MW5007328
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 29, 2008
    Manufacturer
    MENTOR INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FELT A "POP" ON LEFT BREAST. "NEXT DAY NOTICED LEFT BREAST WAS FLAT." DATES OF USE: 1999 - 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SILTEX MAMMARY PROSTHESIS BREAST IMPLANT FWM MENTOR INC. 2600 SILTEX 194340

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other