BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 3794449 · Received May 6, 2014

    Report

    Report Number
    2084725-2014-00163
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLISTERING ON HANDS.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT HISTORY, PREEXISTING MEDICAL CONDITIONS: ADDED ALLERGIC TO GLUTAHALDERHYDE ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD/BATCH RECORD REVIEW, COMPLAINT HISTORY WITH FAILURE MODE TRENDING, FAILURE MODE EFFECTS ANALYSIS, AND SYSTEM HAZARD USE MISUSE ANALYSIS. THE DHR BATCH RECORD REVIEW COULD NOT BE PERFORMED AS THERE WAS NO LOT NUMBER PROVIDED. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''ALLERGIC REACTION¿ WAS REVIEWED FROM AUGUST 2013 THROUGH JULY 2014. THERE WAS NO SIGNIFICANT TREND OBSERVED. TRENDING ANALYSIS FOR THE PRODUCT CODE OF "SKIN REACTION¿ WAS REVIEWED FROM AUGUST 2013 THROUGH JULY 2014. THERE WAS NO SIGNIFICANT TREND OBSERVED. THE FMEA HAS BEEN ASSESSED AND IS BELOW THE THRESHOLD. THE SHUMA HAS BEEN ASSESSED AS LOW AS REASONABLY PRACTICABLE. RETAIN EVALUATION WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. AS INDICATED IN THE CIDEX® INSTRUCTIONS FOR USE (IFU), WEAR SUITABLE PROTECTIVE CLOTHING, GLOVES AND EYE/FACE PROTECTION AND USE ONLY IN WELL-VENTILATED AREAS. THIS PRODUCT CONTAINS GLUTARALDEHYDE WHICH IS IRRITATING TO RESPIRATORY SYSTEM AND SKIN. BRIEF SKIN CONTACT MAY CAUSE ITCHING WITH MILD TO MODERATE LOCAL REDNESS. CONTACT MAY AGGRAVATE EXISTING DERMATITIS. VAPOR IS IRRITATING TO THE RESPIRATORY TRACT, CAUSING STINGING SENSATIONS IN THE NOSE AND THROAT. INHALATION OF VAPOR MAY CAUSE ASTHMA-LIKE SYMPTOMS (CHEST DISCOMFORT AND TIGHTNESS, DIFFICULTY WITH BREATHING). SYMPTOMS WILL USUALLY SUBSIDE ONCE THE HCW IS NO LONGER EXPOSED TO THE PRODUCT. THE INFORMATION RECEIVED IN THE COMPLAINT FILE SUGGESTS THAT THE END CUSTOMER WAS NOT FOLLOWING THE IFU REGARDING PROPER PPE USE WHEN HANDLING CIDEX®. NO SIGNIFICANT TREND WAS FOUND AND NO FURTHER ACTION IS REQUIRED. ASP WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER RECEIVED A REQUEST FROM A FORMER HEALTHCARE WORKER (HCW) WHO USED CIDEX SOLUTION BACK IN THE 1970¿S AND 1980¿S. THE HCW HAS DEVELOPED AN ALLERGY ON HER HANDS AND WANTED TO KNOW IF FORMALIN OR GLUTARALDEHYDE WAS ONE OF THE INGREDIENTS USED IN CIDEX SOLUTION DURING THAT TIMEFRAME. THE HCW STATES HER FIRST REACTION ON HER HANDS OCCURRED IN APPROXIMATELY 1976. THE HCW WAS ASKED TO SCRUB MERCURY THERMOMETERS BY HAND. THE HCW WOULD TAKE THE THERMOMETERS OUT OF THE CIDEX SOLUTION, SCRUB THEM WITH A BRUSH AND PLACE THEM IN CLEAN CIDEX SOLUTION TO DISINFECT. THE HCW WAS TOLD NOT TO WEAR GLOVES AS IT MADE THE THERMOMETERS SLIPPERY. THE HCWS HANDS WOULD ITCH AT THE END OF EACH DAY AND BY THE END OF THE WEEK HER HANDS WERE ¿FULL OF BLISTERS.¿ THE HCW VISITED HER PERSONAL DOCTOR WHO SENT HER TO AN ALLERGIST. THE ALLERGIST TESTED HER FOR GLUTARALDEHYDE AND IT WAS DISCOVERED SHE HAS A SEVERE ALLERGY TO THIS PRODUCT. GLUTARALDEHYDE IS AN INGREDIENT OF CIDEX SOLUTION. THE HCW WAS PRESCRIBED CELLESTODERM AND 1% CLOTRIMAZOLE CREAM TO TREAT HER ALLERGY. THE HCW RETIRED IN 2005 AND HER CURRENT HEALTH STATUS IS ¿HEALTHY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271513 CIDEX ACTIVATED DIALDEHYDE SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1