BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOVE SURGICAL PROTEXIS PI

    MDR report key: 3150441 · Received June 6, 2013

    Report

    Report Number
    1423537-2013-00025
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT ABLE TO PROVIDE THE LOT#, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, SO THE ACTUAL CAUSE COULD NOT BE DETERMINED. HISTORICAL TRENDING WAS DONE. THE CUSTOMER ALSO WAS NOT ABLE TO PROVIDE THE SAMPLE, THE SURGEON¿S AGE/GENDER, OR THE ACTUAL CAT# THAT WAS WORN. THE MEDWATCH IS BEING FILED AGAINST THIS CAT# AS IT IS A SMALLER SIZE. PROTEXIS PI IS THE NEW PRODUCT NAME OF ESTEEM SMT (UNDER BRANDING PROJECT), THERE IS NO CHANGE TO THE GLOVE FORMULATION OR PRODUCTION PROCESS. THE PREVIOUS PRODUCT WAS SUBMITTED FOR THE PRIMARY SKIN IRRITATION TEST, AND THE RESULTS SHOWED THAT THE ESTEEM SMT PASSED THE PRIMARY SKIN IRRITATION TEST. THE EXACT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THE ESTEEM SMT 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 COMPLAINTS FOR ANY UNFAVORABLE TREND.

    Description of Event or Problem · 1

    A SURGEON IN (B)(6) DEVELOPED A SKIN IRRITATION (ACTUAL INCIDENT DATE UNKNOWN), AND THEY HAD PATCH TESTING DONE AT A DERMATOLOGY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250183 GLOVE SURGICAL PROTEXIS PI SURGEONS' GLOVE KGO CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other