BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE-STEP HI-LITE ORANGE

    MDR report key: 11730495 · Received April 27, 2021

    Report

    Report Number
    3004932373-2021-00218
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 20, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. IMDRF ANNEX E CODE HEALTH EFFECT: (B)(4) HYPERSENSITIVITY/ALLERGIC REACTION. IMDRF ANNEX F CODE HEALTH EFFECT: IMPACT CODE: (B)(4) UNANTICIPATED ADVERSE DEVICE EFFECT IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: (B)(4) ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM ((B)(4)).

    Description of Event or Problem · 1

    MATERIAL NO.: 930815 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT 3 PATIENTS EXPERIENCED ITCHING UNDER THE DRESSINGS AFTER CHLORAPREP HAD BEEN USED. OR NURSE AT [OMITTED] STATES THEY PERFORM HAND AND ARM SURGERIES AND USE THE 26ML STERILE CHLORAPREP APPLICATOR 930815. SHE REPORTS HAVE 3 PATIENTS IN THE LAST 10 DAYS EXPERIENCING INTENSE ITCHING UNDER THE DRESSING AFTER SURGERY. THE ARM IS CLEANED WITH CHLORAPREP FROM HAND TO ELBOW PRIOR TO SURGERY AND THEN A DRESSING IS APPLIED FROM FINGERS TO HAND. SHE STATES THEY HAVE BEEN USING THIS PRODUCT AND WANT TO KNOW IF WE MADE ANY CHANGES TO THE SOLUTION DUE TO THE SUDDEN FREQUENT OCCURRENCES. RESPONSE INFORMED THAT NO CHANGES HAVE BEEN MADE TO THE CHLORAPREP SOLUTION. WE HAVE ONLY MADE CHANGES REGARDING STERILIZATION OF THE PRODUCT. DISCUSSED THAT SOME PATIENTS ARE ALLERGIC TO THE SOLUTION, AND IF THE ITCHING IS ONLY LOCALIZED TO THE AREA WHERE THE SOLUTION WAS USED, THAT MAY BE AN INDICATOR. INFORMED THAT THIS INFORMATION WOULD BE SEND TO OUT COMPLAINTS DEPARTMENT. CASE FORWARDED TO PRODUCT COMPLAINTS VIA EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630379 CHLORAPREP ONE-STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other