BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASK WHITE SENSITIVE SECURE GARD

    MDR report key: 1960021 · Received January 13, 2011

    Report

    Report Number
    1423537-2011-00004
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 13, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS PROVIDED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED. WITHOUT THE LOT NUMBER WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD TO DETERMINATE IF ANY DEVIATION TOOK PLACE DURING THE MANUFACTURING PROCESS. IN ADDITION, WITHOUT THE ACTUAL SAMPLE WE ARE ALSO UNABLE TO CONFIRM WHAT THE CUSTOMER EXPERIENCED AND ASSIGN A ROOT CAUSE. 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 10993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. ONLY MATERIALS THAT SUCCESSFULLY COMPLETE THESE TESTS CAN BE COMMERCIALIZED. THIS MASK IS ENGINEERED WITHOUT DYES OR OTHER POTENTIALLY IRRITATING MATERIALS. IN ADDITION, THERE HAVE NOT BEEN ANY MATERIAL CHANGES IN THE MANUFACTURE OF THIS PARTICULAR MASK; THIS MASK IS COMPOSED OF POLYPROPYLENE AND CELLULOSE COMPONENTS. WE WILL CONTINUE TO MONITOR OUR CUSTOMER BASE FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    EMPLOYEES (ESTIMATED BY THE CUSTOMER TO BE 6 INDIVIDUALS) DEVELOPED SENSITIVITIES/RASH WHEN WEARING THE MASK. SOME OF THE EMPLOYEES WENT TO EMPLOYEE HEALTH FOR TREATMENT. OF THESE EMPLOYEES, SOME WERE HELPED BY TREATMENT, AND SOME WERE HELPED BY SWITCHING TO A DIFFERENT MASK. PER THE CUSTOMER, NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASK WHITE SENSITIVE SECURE GARD SURGICAL MASK FXX CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other