BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 11996923 · Received June 14, 2021

    Report

    Report Number
    3004932373-2021-00287
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 14, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    117

    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 BY THE HEALTH PROFESSIONAL THAT PATIENTS DEVELOPED CONTACT DERMATITIS AFTER USE OF CHLORAPREP. PER EMAIL: I HAVE AN ORTHOPEDIC SURGEON FROM OUR FACILITY WITH COMPLAINTS OF SEVERE CONTACT DERMATITIS POST-OP FOLLOWING USE OF THE 26ML ORANGE TINTED CHLORAPREP STICK. APPROXIMATELY 6 PATIENTS IN A TWO WEEK PERIOD IN APRIL DEVELOPED THE CONTACT DERMATITIS IN THE SAME EXTREMITY IN THE SAME AREA AS THE CHLORAPREP WAS APPLIED. A GENERAL SURGEON ALSO CONFIRMED HE HAD ONE CASE OF CONTACT DERMATITIS ON AN ABDOMEN IN THE EXACT AREA WE HAD PREPPED IN THE SAME TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892678 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other