BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION HEALTHCARE PRODUCTS

    MDR report key: 746496 · Received October 11, 2005

    Report

    Report Number
    MW1036900
    Event Type
    Malfunction
    Date Received
    October 11, 2005
    Report Date
    October 11, 2005
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CENTURION HEALTHCARE PRODUCTS, DRESSING CHANGE TRAY, BLUE DYE FROM PACKAGING LEACHED ONTO STERILE GLOVES CONTAINED INSIDE THE PACKAGE. POSSIBLE BREACH OF STERILE CONTENTS. PACKAGE IS ASSEMBLED AND PACKAGED IN A FOREIGN COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION HEALTHCARE PRODUCTS STERILE DRESSING CHANGE TRAY LRP TRI-STATE HOSPITAL SUPPLY CORP. * 904185

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR