BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST IMPLANT

    MDR report key: 13021 · Received April 29, 1994

    Report

    Report Number
    MW1001797
    Event Type
    Malfunction
    Date Received
    April 29, 1994
    Date of Event
    April 13, 1994
    Report Date
    April 13, 1994
    Manufacturer
    UNKNOWN
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT BREAST IMPLANT REMOVED. GEL CENTER INTACT, BUT SALINE SHELL WAS RUPTURED. NO INJURY NOTED TO PT. NO GEL EXTRAVASATION. PT WAS ASYMPTOMATIC. (SAME PT REFERRED TO IN 1001881.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST IMPLANT Implant FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other