BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN SALINE IMPLANT

    MDR report key: 2760144 · Received June 19, 2007

    Report

    Report Number
    2024601-2007-00632
    Event Type
    Malfunction
    Date Received
    June 19, 2007
    Date of Event
    May 18, 2007
    Report Date
    May 22, 2007
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEFT BREAST IMPLANT DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN SALINE IMPLANT FWM

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention