BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 1210757 · Received October 23, 2008

    Report

    Report Number
    1210757
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 20, 2008
    Manufacturer
    MENTOR 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

    PT PRESENTED TO SURGERY CENTER FOR SURGICAL CORRECTION OF DEFLATED LEFT BREAST IMPLANT. ORIGINAL BREAST AUGMENTATION DONE IN 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE BREAST IMPLANT FWM MENTOR CORP. 1600 ROUND 216977

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other