BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST IMPLANT

    MDR report key: 1709665 · Received May 22, 2010

    Report

    Report Number
    1709665
    Event Type
    Malfunction
    Date Received
    May 22, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 19, 2010
    Manufacturer
    UNK
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES SHE HAS HAD LEFT BREAST IMPLANT FOR ABOUT 8 YEARS. CORNER OF IMPLANT PROTRUDES AND IS PAINFUL AND IRRITATED. SHE WOULD LIKE TO HAVE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST IMPLANT BREAST IMPLANT FWM UNK UNK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR