BEUDAMED
    FDA Adverse Event Injury Summary report: N

    153-450

    MDR report key: 668618 · Received January 25, 2006

    Report

    Report Number
    2024601-2006-00054
    Event Type
    Injury
    Date Received
    January 25, 2006
    Date of Event
    October 14, 2005
    Report Date
    December 28, 2005
    Manufacturer
    SANTA BARBARA
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT SIDE CAPSULAR CONTRACTURE, GRADE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 153-450 GEL BREAST IMPLANT FTR SANTA BARBARA STYLE 153 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention