BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWDER-FREE LATEX EXAM GLOVE

    MDR report key: 1833060 · Received August 30, 2010

    Report

    Report Number
    1423507-2010-00038
    Event Type
    Other
    Date Received
    August 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 26, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT ABLE TO IDENTIFY THE LOT NUMBER, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE SAMPLE, THEREFORE, THE ROOT CAUSE COULD NOT BE IDENTIFIED. A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE ALLERGIC REACTIONS TO SOME OF THE ANTI-OXIDANTS AND ACCELERATORS WHICH MAY BE ADDED DURING THE MFG PROCESS. OFTEN REACTIONS MAY BE CAUSED BY CONTACT DERMATITIS AND MAY NOT BE ALLERGIC IN NATURE AT ALL. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE CUSTOMER REPORTED TO CARDINAL HEALTH THAT THREE NURSES HAD IRRITATION ISSUES WITH THE GLOVE. RN DEVELOPED A REACTION ON HER HANDS, AND DRY/BURNING NARES. IT IS KNOWN THAT SHE SOUGHT MEDICAL CARE BUT IT IS NOT KNOWN WHAT TREATMENT WAS GIVEN.

    Additional Manufacturer Narrative · 2

    THE CUSTOMER WAS NOT ABLE TO IDENTIFY THE LOT NUMBER, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE SAMPLE, THEREFORE THE ROOT CAUSE COULD NOT BE IDENTIFIED. A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE ALLERGIC REACTIONS TO SOME OF THE ANTI-OXIDANTS AND ACCELERATORS WHICH MAY BE ADDED DURING THE MFG PROCESS. OFTEN REACTIONS MAY BE CAUSED BY CONTACT DERMATITIS AND MAY NOT BE ALLERGIC IN NATURE AT ALL. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.

    Description of Event or Problem · 2

    ON (B)(6) 2010 THE CUSTOMER REPORTED TO CARDINAL HEALTH THAT THREE NURSES HAD IRRITATION ISSUES WITH THE GLOVE. RN DEVELOPED RASH/BREAKS IN SKIN/PAIN/ITCHING. SHE SOUGHT MEDICAL CARE AND WAS GIVEN HYDROCORTISONE CREAM.

    Additional Manufacturer Narrative · 3

    THE CUSTOMER WAS NOT ABLE TO IDENTIFY THE LOT NUMBER, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE SAMPLE, THEREFORE THE ROOT CAUSE COULD NOT BE IDENTIFIED. A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE ALLERGIC REACTIONS TO SOME OF THE ANTI-OXIDANTS AND ACCELERATORS WHICH MAY BE ADDED DURING THE MFG PROCESS. OFTEN REACTIONS MAY BE CAUSED BY CONTACT DERMATITIS AND MAY NOT BE ALLERGIC IN NATURE AT ALL. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.

    Description of Event or Problem · 3

    ON (B)(6) 2010 THE CUSTOMER REPORTED TO CARDINAL HEALTH THAT THREE NURSES HAD IRRITATION ISSUES WITH THE GLOVE. RN DEVELOPED A RED, BUMPY, ITCHY AND PAINFUL RASH. SHE SOUGHT MEDICAL CARE AND WAS GIVEN CLOBEX LOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWDER-FREE LATEX EXAM GLOVE LATEX PATIENT EXAMINATION GLOVE LYY CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other
    2 30 YR Other
    3 24 YR Other