BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 11871075 · Received May 24, 2021

    Report

    Report Number
    3004932373-2021-00251
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 10, 2021
    Report Date
    August 17, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTO SHOWS A PATIENT WITH WHAT LOOKS TO BE CONTACT DERMATITIS. THIS VERIFIED THE REPORTED ISSUE. WITHOUT A PHYSICAL SAMPLE IT IS NOT POSSIBLE TO DETERMINE IF IN FACT THE CHLORAPREP APPLICATOR HAS AN INCREASED CHG CONCENTRATION, INCREASED IPA CONCENTRATION, CHEMICAL SPECIFICATIONS THAT DO NOT MEET REQUIREMENTS AND/OR INCREASED IMPURITY OR LEACHABLE CONCENTRATIONS AS ESTABLISHED AS POTENTIAL CAUSES. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED AT THIS TIME. A PRODUCTION RECORD REVIEW COULD BE COMPLETED AS THE BATCH/LOT INFORMATION IS UNKNOWN. NO FURTHER ACTIONS ARE REQUIRED. THIS RECORD WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE LITERATURE ARTICLE AUTHOR THAT TWO PATIENTS DEVELOPED ALLERGIC CONTACT DERMATITIS DUE TO COMPOUND ALLERGY INDUCED BY CHLORAPREP WITH TINT. PER ARTICLE: THEREFORE, IN BOTH CASES WE DIAGNOSED ALLERGIC CONTACT DERMATITIS DUE TO COMPOUND ALLERGY INDUCED BY CHLORAPREP WITH TINT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE LITERATURE ARTICLE AUTHOR THAT TWO PATIENTS DEVELOPED ALLERGIC CONTACT DERMATITIS DUE TO COMPOUND ALLERGY INDUCED BY CHLORAPREP WITH TINT. PER ARTICLE: THEREFORE, IN BOTH CASES WE DIAGNOSED ALLERGIC CONTACT DERMATITIS DUE TO COMPOUND ALLERGY INDUCED BY CHLORAPREP WITH TINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769378 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 36 YR Other