BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27-168481

    MDR report key: 527706 · Received May 28, 2004

    Report

    Report Number
    2024601-2004-00312
    Event Type
    Injury
    Date Received
    May 28, 2004
    Date of Event
    July 15, 2003
    Report Date
    April 29, 2004
    Manufacturer
    INAMED CORPORATION (SANTA BARBARA)
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEFT SIDE INFLATION AND CAPSULAR CONTRACTURE. PHYSICIAN STATED THAT HE WILL NOT BE ABLE TO DETERMINE WHETHER OR NOT THE REPORTED EVENT IS PRODUCT RELATED. THEREFORE, THIS EVENT IS BEING REPORTED BECAUSE INAMED'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. THIS MEDWATCH REPORT REPRESENTS THE SAME EVENT REPORTED UNDER MEDWATCH REPORT #2024601-2001-313.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 27-168481 SALINE BREAST IMPLANT FWM INAMED CORPORATION (SANTA BARBARA) STYLE 168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention