BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 1210754 · Received October 20, 2008

    Report

    Report Number
    1210754
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 29, 2008
    Manufacturer
    INAMED CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREVIOUS BILATERAL SALINE BREAST IMPLANTS 1999. PRESENTED NOW WITH PARTIAL DEFLATION RIGHT BREAST IMPLANT. IN FOR BILATERAL REMOVAL OF SALINE IMPLANTS, CAPSULOTOMY. IMPLANT OF BILATERAL GEL IMPLANTS & RIGHT MASTOPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE BREAST IMPLANT RIGHT FWM INAMED CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR