BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 21399 · Received February 9, 1995

    Report

    Report Number
    21399
    Event Type
    Malfunction
    Date Received
    February 9, 1995
    Date of Event
    December 13, 1994
    Report Date
    January 31, 1995
    Manufacturer
    UNKNOWN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON DECEMBER 13, 1994, A 51 YEAR OLD PATIENT HAD LEFT BREAST IMPLANT REMOVED. IT WAS PLACED DURING THE EARLY 1970'S. THE SURGEON FOUND THE IMPLANT RUPTURED. CULTURE WAS OBTAINED. THE PROCEDURE WAS DONE AS AN OUTPATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other