BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIMBERLY-CLARK PURPLE NITRILE EXAM GLOVES

    MDR report key: 865769 · Received June 15, 2007

    Report

    Report Number
    9680760-2007-00076
    Event Type
    Other
    Date Received
    June 15, 2007
    Date of Event
    May 2, 2007
    Report Date
    June 15, 2007
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    FMC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE GLOVES HAVE BEEN RECEIVED AND ARE BEING EVALUATED. THE RESULTS OF THE EVALUATION ARE NOT YET AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED COMPLAINT OF POWDER INSIDE GLOVES WITH EMPLOYEE ALLERGIC REACTION. EMPLOYEE HEALTH NURSE REPORTED THAT A LAB PHLEBOTOMIST REPORTED SEVERE ALLERGIC REACTION ABOUT TWO WEEKS AGO. THIS WAS A PREGNANT WOMAN, NEARING TERM, WHO HAS WORN BOTH THE STERLING NITRILE AND PURPLE NITRILE GLOVES. IT IS NOT KNOWN WHICH GLOVE WAS BEING WORN AT THE TIME OF THE REACTION. THE GLOVES WERE REMOVED AND HANDS WASHED. DESPITE THIS, SHE DEVELOPED A RED RASH OVER HANDS, TRUNK AND BACK. SHE LEFT WORK AND WAS SEEN BY HER OBSTETRICIAN. HE WAS UNABLE TO SAY WHETHER THIS WAS AN AUTOIMMUNITY CONCERN, OFTEN SEEN DURING PREGNANCY, OR WHETHER THIS WAS TRULY FROM THE GLOVES. HE DID PRESCRIBE A TAPERING DOSE OF STEROIDS AS TREATMENT. APPROXIMATELY 7-10 DAYS LATER, SHE DONNED GLOVES AND EXPERIENCED A MILDER REACTION WITH THE GLOVES. SHE HAS SINCE STOPPED WEARING KIMBERLY-CLARK GLOVES AND CHANGED TO ANOTHER BRAND. THE RASH HAS RESOLVED. KIMBERLY-CLARK HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS BUT IS RELAYING THE INFORMATION RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK PURPLE NITRILE EXAM GLOVES EXAM GLOVES FMC KIMBERLY-CLARK CORPORATION NA SC62535XX

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other