BEUDAMED
    FDA Adverse Event Summary report: N

    GLOVE INSTAGARD PF SYN EXAM (VINYL) SZ S

    MDR report key: 2010349 · Received March 8, 2011

    Report

    Report Number
    1423537-2011-00010
    Date Received
    March 8, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 29, 2011
    Product Code
    LYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH HAS FILED THE INITIAL MEDWATCH AND IS FILING THIS FOLLOW UP REPORT AS THE IMPORTER. THE SAMPLE WAS RECEIVED AND EVALUATED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO ABNORMALITIES WERE NOTED. HISTORICAL TRENDING WAS DONE. A STIMULATION TEST WAS DONE WITH THE RETURNED SAMPLE, AND THE RESULTS WERE THAT NO ONE DEVELOPED AN ALLERGIC PHENOMENON. A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE AN ALLERGIC REACTION TO SOME OF THE ANTI-OXIDANTS AND ACCELERATORS WHICH MAY BE ADDED DURING THE MANUFACTURING PROCESS. SOME REACTIONS MAY BE CAUSED BY CONTACT DERMATITIS, AND MAY NOT BE ALLERGIC IN NATURE. THE SUPPLIER HAS BEEN APPRAISED OF THIS REPORTED INCIDENT FOR CLOSE MONITORING OF THE MANUFACTURING PROCESS. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    COMPLAINT AND SAMPLE FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. FOLLOW UP REPORT WILL BE FILED WHEN RESULTS OF INVESTIGATION ARE COMPLETED.

    Description of Event or Problem · 1

    FEMALE EMPLOYEE'S HANDS WERE RED/INFLAMED LIKE A FIRST DEGREE BURN, WITH EXCORIATION CLOSE TO THE WRISTS AND BASE OF HER PALMS. ORIGINALLY IT WAS THOUGHT THAT THIS WAS DUE TO THE ALCOHOL HAND SANITIZER BEING USED, SHE NOW BELIEVES IT IS THE GLOVE. SHE WAS SENT HOME FROM WORK AND IT IS BELIEVED SHE WAS GIVEN PRESCRIPTIVE MEDICATION. SHE IS USING A DIFFERENT GLOVE NOW WITHOUT PROBLEMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LEARNED - THE EMPLOYEE'S AGE AND WEIGHT, AND THAT HER JOB TITLE IS (B)(6). SHE HAS NOT HAD ALLERGIES, OR ALLERGY TESTING IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVE INSTAGARD PF SYN EXAM (VINYL) SZ S VINYL PATIENT EXAM GLOVE LYZ 1T10J011

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other