BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATH

    MDR report key: 6459717 · Received April 5, 2017

    Report

    Report Number
    3007420694-2017-00074
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Report Date
    April 5, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARJOHUNTLEIGH WAS MADE AWARE ABOUT AN INCIDENT THAT TOOK PLACE IN (B)(6) NURSING. IT WAS REPORTED THAT DURING ATTEMPTING TO DILUTE CEN KLEEN IV, SOME OF THE UN-DILUTED PRODUCT WAS REPORTED TO SPLASH ONTO THE SKIN OF TWO STAFF MEMBERS. THEY BOTH FELT A BURNING SENSATION TO THEIR SKIN BUT IMMEDIATELY WASHED OFF THE UNDILUTED PRODUCT ACCORDING TO LABELED INSTRUCTION AND NO MEDICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED. NO INFORMATION HAS BEEN DISCLOSED REGARDING THE DEVICE THAT WAS ATTEMPTED TO BE DISINFECTED, BUT THIS PRODUCT IS RECOMMENDED TO BE USED WITH ARJOHUNTLEIGH BATHING SYSTEMS. AS THE COMPLAINT DESCRIPTION INDICATED INVOLVEMENT OF TWO CAREGIVERS, SEPARATE COMPLAINT FILES HAVE BEEN CREATED AND EVALUATION OF EACH EVENT DECIDED TO BE REPORTED UNDER (MFR REP NO. 3007420694-2017-00073 AND MFR REP NO. 3007420694-2017-00074). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT (MFR REP NO. 3007420694-2017-00074). WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A VERY LOW NUMBER OF CASES THAT MAY RELATE TO THE ISSUE INVESTIGATED HERE: UNDILUTED CEN KLEEN IV DISINFECTANT SPLASHED ONTO THE SKIN. ALTHOUGH THERE HAD NEVER BEEN REPORTED SERIOUS INJURY IN RELATION TO SIMILAR INADEQUATE SEQUENCE OF ACTIONS TAKEN BY THE CAREGIVER, USING CEN KLEEN IV IN THAT INAPPROPRIATE WAY MIGHT CAUSE SKIN BURNS OR EYE DAMAGE WHEN SPLASHED ON THE USER. THEREFORE IT WAS DECIDED TO REPORT THIS COMPLAINT IN ABUNDANCE OF CAUTION. CEN-KLEEN IV IS A HOSPITAL GRADE, "ONE STEP" QUATERNARY AMMONIUM-TYPE DISINFECTANT AND CLEANER CONTAINING BLEND OF GERMICIDAL INGREDIENTS AND DETERGENTS. IT IS DESIGNED FOR USE WITH ARJOHUNTLEIGH BATHING SYSTEMS AND IS A VERSATILE CHOICE FOR DISINFECTION PROGRAMS DESIGNED TO REDUCE BACTERIAL CONTAMINATION OF TUBS, ETC. IN ACCORDANCE TO CEN-KLEEN IV INSTRUCTION FOR USE PRESENTED ON THE PRODUCT LABEL, CERTAIN PERSONAL PROTECTIVE EQUIPMENT SHALL BE USED: "HAZARDS TO HUMANS AND DOMESTIC ANIMALS. DANGER. CORROSIVE. CAUSES IRREVERSIBLE EYE DAMAGE AND SKIN BURNS. DO NOT GET IN EYES, ON SKIN OR ON CLOTHING. WEAR PROTECTIVE EYEWEAR (GOGGLES, FACE SHIELD OR SAFETY GLASSES), PROTECTIVE (RUBBER OR CHEMICAL RESISTANT) GLOVES AND PROTECTIVE CLOTHING. HARMFUL IF SWALLOWED OR ABSORBED THROUGH THE SKIN." THE PRODUCT LABEL ALSO WARNS: "DIRECTIONS FOR USE: IT IS A VIOLATION OF FEDERAL LAW TO USE THIS PRODUCT IN A MANNER INCONSISTENT WITH ITS LABELING." IN THIS PARTICULAR COMPLAINT, THE INVOLVED CAREGIVERS WERE NOT WEARING PROTECTIVE CLOTHING WHICH REPRESENTS USING THE PRODUCT IN A MANNER INCONSISTENT WITH CEN-KLEEN DISINFECTANT LABELING. FROM OUR EVALUATION WE CONSIDER THIS EVENT TO BE ACTING AGAINST THE PRODUCT LABELING WHERE THE USER WAS NOT WEARING PROTECTIVE CLOTHING AND WAS NOT CAREFUL ENOUGH TO AVOID CONTACT OF THE DISINFECTANT WITH THE SKIN. THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF INSTRUCTIONS CONCERNING PRODUCT HANDLING WERE FOLLOWED IN ACCORDANCE TO THE LABELING, THERE WOULD BE NO PATIENT OR CAREGIVER AT RISK.

    Description of Event or Problem · 1

    ARJOHUNTLEIGH WAS MADE AWARE ABOUT AN INCIDENT THAT TOOK PLACE IN (B)(6) NURSING HOME. IT WAS REPORTED THAT DURING ATTEMPTING TO DILUTE CEN KLEEN IV, SOME OF THE UN-DILUTED PRODUCT WAS REPORTED TO SPLASH ONTO THE SKIN OF TWO STAFF MEMBERS. THEY BOTH FELT A BURNING SENSATION TO THEIR SKIN BUT IMMEDIATELY WASHED OFF THE UNDILUTED PRODUCT ACCORDING TO LABELED INSTRUCTION AND NO MEDICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242594 BATH BATH, HYDRO-MASSAGE ILJ ARJOHUNTLEIGH POLSKA SP. Z O.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other