BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11648418 · Received April 12, 2021

    Report

    Report Number
    3004932373-2021-00191
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 23, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DEFINE A PROBABLE ROOT CAUSE. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0283167 AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE RECORD WILL BE REOPENED AND PROCESSED ACCORDINGLY. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ADVERSE EVENT WHERE IT WAS NEEDED TO ADMINISTER HYDROCORTISONE TO THE PATIENTS PREVIOUSLY REPORTED ((B)(4)), AND BY THE END OF 1 HOUR LATER THE PAPULES WERE GONE. THERE WAS A NEW PATIENT ON (B)(6) 2021, WHERE IT WAS ADMINISTERED MEDICATION. ((B)(6), 01.APR.2021) AT THE FIRSTS TWO CASES ((B)(4)), THOSE TWO PATIENTS WERE NOT NEEDED TO TAKE MEDICATIONS, BOTH HAVE GOTTEN BETTER WITH NO INTERVENTION. THE 3RD PATIENT (THIS (B)(4)) ONLY, THE HEALTH CARE PROFESSIONAL REPORTS THAT IT WAS NEEDED TO GIVE THE HYDROCORTISONE. THEY FURTHER REPORT THAT THERE WAS NO CHANGE IN ANY OF THE ANTISEPSIS PROCEDURES.

    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

    IT WAS REPORTED AN ADVERSE EVENT WHERE IT WAS NEEDED TO ADMINISTER HYDROCORTISONE TO THE PATIENTS PREVIOUSLY REPORTED (PR# (B)(4)), AND BY THE END OF 1 HOUR LATER THE PAPULES WERE GONE. THERE WAS A NEW PATIENT ON MAR. 29TH, WHERE IT WAS ADMINISTERED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547449 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0283167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other