BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAND SANITIZER, EPI CLENZ PLUS

    MDR report key: 1291845 · Received January 19, 2009

    Report

    Report Number
    1417592-2009-00004
    Event Type
    Other
    Date Received
    January 19, 2009
    Report Date
    January 14, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KOY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STAFF MEMBER EXHIBITED AN ALLERGIC RESPONSE AFTER USING THE HAND SANITIZER. SHE HAD A RASH ON HER HANDS. SHE WAS EVALUATED IN THE EMERGENCY ROOM, GIVEN ORAL STEROIDS AND RELEASED. SHE HAD NO KNOWN ALLERGIES. DUE TO ALLERGIC REACTION THAT DEVELOPED AND THE SUBSEQUENT MEDICAL INTERVENTION, A MDR IS BEING FILED.

    Description of Event or Problem · 1

    A STAFF MEMBER DEVELOPED AN ALLERGIC RESPONSE AFTER COMING IN CONTACT WITH THE PRODUCT. SHE WAS EVALUATED IN THE ER, GIVEN ORAL STEROIDS AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND SANITIZER, EPI CLENZ PLUS NONE KOY MEDLINE INDUSTRIES, INC. MSC097028 811131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention