BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12136135 · Received July 8, 2021

    Report

    Report Number
    3004932373-2021-00317
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    October 8, 2019
    Report Date
    June 28, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY (B)(6). PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONTACT DERMATITIS USING CHLORAPREP. PER COMPLAINT DETAILS RECEIVED: THIS CASE WAS DETECTED IN THE MEDICAL LITERATURE BY THE EMA MLM SERVICE LAURIOLA MM, CORAZZA M. ALLERGIC CONTACT DERMATITIS DUE TO A PREOPERATIVE ANTISEPTIC SOLUTION. CONTACT DERMATITIS. 2021 ON (B)(6) 2021. THIS CASE WAS ALSO DETECTED BY BECTON DICKINSON (B)(4) ON 10/05/2021 AND TRANSMITTED TO EUDRAVIGILANCE ON 19/05/2021 WITH CASE NUMBER (B)(4). IN ACCORDANCE WITH THE MLM SERVICE DUPLICATE MANAGEMENT PROCESS, THIS CASE IS BASED ON THAT FIRST E2B TRANSMISSION. THIS SPONTANEOUS CASE WAS REPORTED IN THE MEDICAL LITERATURE BY A PHYSICIAN FROM (B)(6) AND CONCERNS A (B)(6) MALE PATIENT WHO EXPERIENCED A NON-SERIOUS ADVERSE REACTION OF ACUTE CONTACT DERMATITIS ASSOCIATED WITH CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL. THE PATIENT WHO WAS ATOPIC MAN DEVELOPED AN ACUTE ERYTHEMATO-EDEMATOUS AND VESICULAR REACTION OF THE RIGHT DELTOID REGION, AXILLARY CAVITY, UPPER LIMB, AND IPSILATERAL HEMITHORAX. TEN DAYS EARLIER THE PATIENT HAD UNDERGONE SHOULDER ACROMIOPLASTY AND ROTATOR CUFF RECONSTRUCTION SURGERY WITH THE USE OF SUTURES IN TITANIUM ALLOY. THE ONLY ANTISEPTIC THAT HAD BEEN USED DURING THE SURGERY WAS CHLORAPREP WITH TINT, A CUTANEOUS SOLUTION OF CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70%, PURIFIED WATER, AND SUNSET YELLOW (E110) IN A PLASTIC APPLICATOR WITH A SPONGE TIP ON ONE END. TWO DAYS AFTER THE SURGERY HE HAD APPLIED KETOPROFEN PAIN RELIEF 10% GEL, WITH IBUPROFEN LYSINE SALT, AND PURE LAVENDER ESSENTIAL OIL. THE DERMATITIS HEALED WITH SYSTEMIC STEROIDS AND A TOPICAL COMBINATION OF STEROID AND ANTIBIOTIC. AFTERWARD, PATCH TESTS WERE PERFORMED WITH THE SIDAPA BASELINE SERIES WITH FIRMA INTEGRATION, THE INTEGRATIVE ORTHOPEDIC SERIES, THE PREOPERATIVE ANTISEPTIC SOLUTION USED (CHLORAPREP WITH TINT, TESTED ¿AS IS¿), KETOPROFEN PAIN RELIEF 10% GEL ¿AS IS,¿ AND COMMERCIAL ALLERGEN OF LAVENDER OIL 2% PET., ON VAN DER BEND CHAMBERS. PATCH TESTS WERE APPLIED UNDER OCCLUSION ON THE PATIENT'S BACK FOR 2 DAYS; READINGS WERE PERFORMED ON DAY (D)2 AND D4 ACCORDING ESCD GUIDELINES. THE PATIENT SHOWED POSITIVE REACTIONS TO CHLORAPREP WITH TINT (++D2/++D4), TO MYROXYLON PEREIRAE (+D2/+D4), AND TO FRAGRANCE MIX I (+D2/+D4). CHLORHEXIDINE DIGLUCONATE 0.5% AQ. AND THE ADDITIONALLY TESTED COMMERCIAL HAPTENS ISOPROPYL ALCOHOL 10% AQ. AND SUNSET YELLOW 2% PET. GAVE NEGATIVE RESULTS. CHLORAPREP WITH TINT IS A COMBINATION OF ISOPROPYL ALCOHOL, CHLORHEXIDINE, AND SUNSET YELLOW E110 (AN AZO DYE THAT PLAYS NO ROLE IN THE ANTISEPTIC PROPERTIES OF THE SOLUTION) USED AS A PREOPERATIVE ANTISEPTIC SOLUTION. CHLORHEXIDINE CAN CAUSE ALLERGIC CONTACT DERMATITIS, AND IT MAY RARELY INDUCE IMMUNOLOGICAL CONTACT URTICARIA AND EVEN ANAPHYLAXIS. ISOPROPYL ALCOHOL, A SECONDARY ALCOHOL USED AS A PRESERVATIVE, ANTISEPTIC, AND INDUSTRIAL SOLVENT, IS KNOWN TO BE A MILD IRRITANT AND ALSO A WEAK SENSITIZE. IN THIS CASE IT WAS FOUND A POSITIVE REACTION TO THE TOPICAL PREPARATION CHLORAPREP WITH TINT, TESTED ¿AS IS,¿ WITH NEGATIVE RESULTS TO ALL THE INDIVIDUAL INGREDIENTS, SUGGESTING THE UNUSUAL DIAGNOSIS OF COMPOUND ALLERGY FOR BOTH PATIENTS. IN CONCLUSION, THIS CASE ALSO EMPHASIZES THAT A SYSTEMATIC APPROACH WITH A CAREFUL ANAMNESIS AND PROPER PATCH TESTING IS CRUCIAL TO EFFECTIVELY EVALUATE SUSPECTED CONTACT DERMATITIS. FOLLOW-UP INFORMATION HAS BEEN REQUESTED. ALSO REFER LINKED CASE #(B)(4). INITIAL INFORMATION WAS PROCESSED ALONG WITH THE FOLLOW-UP INFORMATION RECEIVED FROM THE AUTHOR ADDITIONAL INFORMATION ADDED FOLLOWING THE RECEIPT OF AUTHOR INFORMATION ON 16 JUN 2021 THE PATIENT WAS SLIGHTLY OVERWEIGHT. THE PATIENT WAS A NON-SMOKER AND NON-ALCOHOLIC. A LOCAL SKIN APPLICATION WITH CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL FOR PREOPERATIVE ANTISEPSIS WAS INITIATED AT ONCE ON (B)(6) 2019. THE PATIENT WAS NOT HOSPITALIZED DUE TO EVENT. ON (B)(6) 2019, THE PATIENT HAS EXPERIENCED ACUTE CONTACT DERMATITIS AND WAS REPORTED AS RESOLVED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037483 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other