BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 2192945 · Received November 16, 2007

    Report

    Report Number
    2192945
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    November 12, 2007
    Report Date
    November 16, 2007
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANTS RUPTURED INSIDE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention