BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3082348 · Received April 8, 2013

    Report

    Report Number
    3082348
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 29, 2013
    Manufacturer
    UNK
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    RIGHT BREAST IMPLANT LEAKED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142728 * PROSTHESIS, BREAST FTR UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR