BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12548796 · Received September 29, 2021

    Report

    Report Number
    3004932373-2021-00450
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 24, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    MATERIAL NO: 930815. BATCH NO: UNKNOWN. IT WAS REPORTED THAT VERBATIM: PER CUSTOMER ¿WE HAVE HAD A HANDFUL OF PATIENTS THAT HAVE HAD A BAD REACTION TO THE CHLORAPREP WITH SKIN IRRITATION/HIVES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446954 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other