BEUDAMED
    FDA Adverse Event Summary report: N

    KINDEST KARE FOAM ANTISEPTIC HANDRUB

    MDR report key: 3232947 · Received July 18, 2013

    Report

    Report Number
    1937531-2013-00004
    Date Received
    July 18, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 17, 2013
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS PERSONNEL CONTACTED THE HOSPITAL DIRECTOR TO OBTAIN MORE INFORMATION REGARDING THE REPORTED EVENT. DISCUSSION WITH THE HOSPITAL DIRECTOR REVEALED THAT THREE (3) PATIENTS REMOVED THE FOAM DISPENSER FROM THE WALL AND CONSUMED A PORTION OF THE CONTENTS OF THIS OTC ANTISEPTIC HANDWASH PRODUCT CONTAINING ISOPROPYL ALCOHOL. FOLLOWING INGESTION, THE PATIENTS SHOWED SIGNS OF INTOXICATION; ONE PATIENT APPEARED MORE INTOXICATED THAN THE OTHERS AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. EXAMINATION OF THE PRODUCT REVEALED THAT NO MORE THAN HALF OF THE CONTAINER WAS CONSUMED BY EACH PATIENT. ALL THREE PATIENTS WERE GIVEN FLUIDS. THE KINDEST KARE PRODUCT LABEL STATES 'FOR EXTERNAL USE ONLY. IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.'

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PREVIOUSLY ADMITTED PATIENT OPENED A KINDEST KARE FOAM DISPENSER BY UNSCREWING THE CAP, AND DRANK AN UNKNOWN QUANTITY OF THE PRODUCT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AFTER REPORTS OF ¿INTOXICATED BEHAVIOR¿. THE PATIENT IS REPORTED TO HAVE MADE A FULL RECOVERY WITH NO SUSTAINING INJURIES. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336333 KINDEST KARE FOAM ANTISEPTIC HANDRUB ANTISEPTIC HANDRUB LRJ STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other