BEUDAMED
    FDA Adverse Event Other Summary report: N

    MASK WHITE SENSITIVE SECURE GARD

    MDR report key: 1202765 · Received October 13, 2008

    Report

    Report Number
    1423507-2008-00080
    Event Type
    Other
    Date Received
    October 13, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 10, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH SAMPLES FOR THE INVOLVED LOT NUMBER WERE NOT RETURNED, THE MATERIALS USED IN THE MANUFACTURE OF THIS PARTICULAR LOT MET SPECIFICATIONS. THIS MASK IS COMPOSED OF POLYPROPYLENE AND CELLULOSE COMPONENTS. THERE HAVE NOT BEEN ANY MATERIAL CHANGES. DURING THE PRODUCT DEVELOPMENT PHASE, ALL MATERIALS USED FOR THE MASK WERE EVALUATED FOR BIOCOMPATIBILITY. THE TESTING WAS PERFORMED IN ACCORDANCE WITH INTERNATIONAL STANDARD ISO BIOLOGICAL EVALUATION OF MEDICAL DEVICES. ONLY MATERIALS THAT SUCCESSFULLY COMPLETED THESE TESTS CAN BE COMMERCIALIZED. THE TESTS UTILIZED ARE DESIGNED TO PREDICT THE SAFETY OF THE PRODUCT FOR THE GENERAL POPULATION OF USERS. UNFORTUNATELY, NO TEST OR SERIES OF TEST CAN GUARANTEE THAT A PARTICULAR ITEM WILL BE COMPATIBLE WITH ALL USERS. WE CAN NOT DETERMINE THE EXACT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    SURGEON DEVELOPED RHINITIS. HE RECEIVED MEDICAL TREATMENT WITH CORTISONE AND AN ANTIHISTAMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASK WHITE SENSITIVE SECURE GARD SURGICAL MASK FXX CARDINAL HEALTH 08EAH141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other