BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTA GARD FLUID RESISTANT SURGICAL TIE

    MDR report key: 1961552 · Received January 14, 2011

    Report

    Report Number
    1423537-2011-00005
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 14, 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

    BASED ON THE LOT NUMBER PROVIDED, NO ISSUE OF THIS KIND WAS DETECTED DURING THE MANUFACTURE OF THIS CODE. THE ACTUAL SAMPLE WAS NOT PROVIDED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, WE ARE UNABLE TO CONFIRM WHAT THE CUSTOMER EXPERIENCED OR ASSIGN A ROOT CAUSE. TWO REPRESENTATIVE SAMPLES WERE RECEIVED. WE CAN NOT CONFIRM THAT THE "ISSUE" MASK WAS FROM THE REPRESENTATIVE SAMPLES SENT. A VISUAL EXAMINATION WAS CONDUCTED ON THE SAMPLES PROVIDED, AND NO VISUAL DEVIATIONS OF THE COMPONENT MATERIALS WAS PRESENT. 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. THE MATERIALS USED IN THE MANUFACTURE OF THIS PARTICULAR MASK LOT MET SPECIFICATIONS; THERE HAVE NOT BEEN ANY MATERIAL CHANGES. 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) BROKE OUT IN A 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 INSTA GARD FLUID RESISTANT SURGICAL TIE SURGICAL MASK FXX CARDINAL HEALTH 10EBH146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other