BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3113318 · Received May 6, 2013

    Report

    Report Number
    3113318
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    UNK
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT FELT ONE IMPLANT HAD RUPTURED AND WAS CONFIRMED ON MAMMOGRAM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BREAST IMPLANT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195964 * PROSTHESIS, BREAST FWM UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR