BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOVE SURGICAL PROTEXIS PI CLASSIC

    MDR report key: 3728372 · Received April 4, 2014

    Report

    Report Number
    1423537-2014-00013
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE SAMPLE OR THE LOT#, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE PROTEXIS PI CLASSIC GLOVE IS THE NEW PRODUCT NAME OF THE ESTEEM GLOVE, THERE IS NO CHANGE TO THE GLOVE FORMULATION OR THE PRODUCTION PROCESS. PREVIOUSLY THIS PRODUCT PASSED THE TEST FOR PRIMARY SKIN IRRITATION PER THE TECHNICAL SERVICE REPORT. THE EXACT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THE ESTEEM GLOVE (NOW CALLED PROTEXIS PI CLASSIC) HAS 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.

    Description of Event or Problem · 1

    MALE EMPLOYEE REPORTED SKIN RASH AND IRRITATION. RECEIVED HYDROCORTISONE CREAM AND HAD TO LEAVE WORK. WAS OFF FROM WORK THREE DAYS. HE HAS SWITCHED TO A DIFFERENT GLOVE. THE ACTUAL EVENT DATE IS NOT KNOWN, IT MAY HAVE BEEN (B)(6) 2013 OR (B)(6) 2014. USED THE DATE OF (B)(6) 2014 WHICH IS WHEN THE COMPLAINT WAS REPORTED TO CARDINAL HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204309 GLOVE SURGICAL PROTEXIS PI CLASSIC SURGEON'S GLOVES KGO CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other