BEUDAMED
    FDA Adverse Event Summary report: N

    CASTLE STERILIZER

    MDR report key: 10535 · Received August 17, 1993

    Report

    Report Number
    MW4000026
    Date Received
    August 17, 1993
    Date of Event
    August 15, 1993
    Manufacturer
    MDT BIOLOGIC CO.
    Product Code
    FLE
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FLAST STERILIZER USED FOR EQUIPMENT TO OBTAIN MAMMARY VESSELS. TEMP TRACING OK. EQUIPMENT USED ON PT. NEXT BIOLOGIC TEST NOT EFFECTIVE. ARE PTS IDENTIFIED THAT WERE SUSCEPTIBLE. ONE PT CAME DOWN WITH STERNAL INFECTION AND IS BEING TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE STERILIZER FLE MDT BIOLOGIC CO. 3020

    Patients

    Seq Age Sex Outcome Treatment
    1 *