BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11558856 · Received March 23, 2021

    Report

    Report Number
    3004932373-2021-00143
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 15, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.: 930815. BATCH NO.: UNKNOWN. IT WAS REPORTED THE PATIENT HAD A RASH BREAKOUT REACTION. PER COMPLAINT FORM: MET DR. (B)(6) [OMITTED] IN (B)(6) BEFORE HER LAPAROSCOPIC HYSTERECTOMY CASE. DR. {OMITTED] MENTIONED THAT A FEW WEEKS AGO SHE HAD TWO SEPARATE PATIENTS THAT HAD BAD REACTIONS TO CHLORAPREP AFTER BEING PREPPED AT (B)(6). ONE PATIENT HAD THE CHLORAPREP 26ML ORANGE TINT ADMINISTERED, AND THE SECOND PATIENT HAD THE CHLORAPREP 26ML TEAL TINT ADMINISTERED AND BOTH PATIENTS HAD SIMILAR RASH BREAKOUT REACTIONS. DR. [OMITTED] ASKED ME IF THE FORMULATION HAD BEEN CHANGED, AND I SAID THAT THE ONLY DIFFERENCE IS THAT THE PRODUCT IS NOW DEEMED STERILE. DR. [OMITTED] WANTED ME TO PASS THIS INFORMATION UP THE CHAIN-OF-COMMAND. TWO SEPARATE PATIENTS NEEDED TO BE ADMINISTERED STEROID MEDICATIONS FOR THE BAD RASH. ONE PATIENT HAD A BAD ABDOMINAL RASH, AND A SEPARATE PATIENT HAD AN ABDOMINAL RASH AND RASH ON HER BACK WHERE CHLORAPREP HAD BEEN PREPPED FOR AN EPIDURAL. I ASKED DR. IF THE PROPER 3 MINUTE DRY-TIME WAS FOLLOWED, AND SHE SAID IT HAD BEEN FOLLOWED PROPERLY. NOT SURE IF PATIENTS HAD CHG ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452824 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other