BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOVE SURGICAL PROTEXIS PI

    MDR report key: 4223674 · Received November 4, 2014

    Report

    Report Number
    1423537-2014-00029
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 6, 2014
    Report Date
    November 4, 2014
    Manufacturer
    CARDINAL HEALTH (THAILAND) 222 LIMITED
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. NO SAMPLE WAS PROVIDED. PREVIOUSLY THIS PRODUCT PASSED THE TEST FOR PRIMARY SKIN IRRITATION PER THE TECHNICAL SERVICE REPORT. THERE HAS BEEN NO CHANGE TO THE GLOVE FORMULATION OR PRODUCTION PROCESS. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THE PROTEXIS PI GLOVES HAVE PASSED A SERIES OF TESTS PRESCRIBED BY REGULATORY AGENCIES FOR THE INTENDED USE. HOWEVER, THE POSSIBILITY OF SOME INDIVIDUALS EXPERIENCING REACTIONS TO CERTAIN CHEMICALS USED DURING THE MANUFACTURING PROCESS CANNOT BE RULED OUT. WE WILL CONTINUE TO MONITOR OUR COMPLAINTS FOR ANY TRENDS WHICH MIGHT REQUIRE FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    SURGICAL TECH WORE THE GLOVE WITHOUT PROBLEMS DURING THE GLOVE TRIAL. SEVERAL PRODUCTS CHANGED IN THE WORK ENVIRONMENT (INCLUDING HAND ANTISEPTIC). SHE TRIED THE PROTEXIS GLOVE AGAIN, AND NOW DEVELOPED ITCHING. ONE DAY, AFTER DEVELOPING THE ITCHING, SHE PUT HER RINGS BACK ON. HER HANDS SWELLED UP AND SHE COULDN¿T GET HER RINGS OFF. SHE NEEDED TO HAVE HER RINGS CUT OFF AND THEN REPAIRED. SHE SELF-MEDICATED WITH TRIAMCINOLONE CREAM (WHICH SHE ALREADY HAD), AND IT HELPED. SHE IS DOING WELL NOW AND HAS FOUND A GLOVE SHE CAN USE WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705600 GLOVE SURGICAL PROTEXIS PI SURGEON'S GLOVES KGO CARDINAL HEALTH (THAILAND) 222 LIMITED NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other