BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 11639703 · Received April 9, 2021

    Report

    Report Number
    3004932373-2021-00183
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 9, 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).

    Description of Event or Problem · 1

    MATERIAL NO.: UNKNOWN ; BATCH NO.: UNKNOWN. IT WAS REPORTED PATIENT WAS DIAGNOSED WITH CONTACT DERMATITIS TO CHLORHEXIDINE CONFIRMED BY ECZEMATOUS RASH ON LEFT PREAURICULAR REGION. PER LITERATURE: AFTER INVESTIGATING WHICH ANTISEPTICS WERE USED DURING THE VACCINATIONS, WE DECIDED TO TEST CHLORHEXIDINE DIGLUCONATE 0.5% AQ. THAT WAS POSITIVE AT BOTH DAY 2 AND DAY 4 (FIG 1C). A DIAGNOSIS OF ALLERGIC CONTACT DERMATITIS TO CHLORHEXIDINE WAS MADE, CONFIRMED BY AN ECZEMATOUS RASH ON LEFT PREAURICULAR REGION APPEARED AFTER MOTHER'S APPLICATION OF ANTISEPTIC SOLUTION BASED ON CHLORHEXIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538272 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other