BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLV SURG ESTEEM NEU-THERA PF SYN SZ 7.0

    MDR report key: 1873887 · Received October 19, 2010

    Report

    Report Number
    1423537-2010-00055
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    February 22, 2010
    Report Date
    October 18, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER WAS PROVIDED BY THE CUSTOMER, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE PRODUCT PASSED THE REQUIREMENTS OF THE PRIMARY SKIN IRRITATION TEST PER THE TECHNICAL SERVICES REPORT. THE EXACT CAUSE OF THE SKIN IRRITATION COULD NOT BE DETERMINED. THE ESTEEM NEU-THERA GLOVE HAS PASSED A SERIES OF TESTS PRESCRIBED BY REGULATORY AGENCIES FOR THE INTENDED USE. HOWEVER, THE POSSIBILITY OF AN INDIVIDUAL EXPERIENCING A REACTION TO CERTAIN CHEMICALS THAT ARE USED DURING THE MANUFACTURING PROCESS CANNOT BE RULED OUT. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.

    Description of Event or Problem · 1

    FEMALE SURGICAL TECHNICIAN DEVELOPED RED/RAW/INFLAMED HANDS AFTER WEARING THE GLOVE. HER HANDS ALSO HURT TO MOVE, AND SHE WAS OFF FROM WORK. SHE SAW A PHYSICIAN AND HAD TESTING DONE. THE PHYSICIAN'S OFFICE CONTACTED CARDINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLV SURG ESTEEM NEU-THERA PF SYN SZ 7.0 SURGEON'S GLOVE KGO CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other