BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11189360 · Received January 18, 2021

    Report

    Report Number
    3004932373-2021-00004
    Event Type
    Injury
    Date Received
    January 18, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 8, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PR 2264098 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY FRANCISCAN SURGERY CENTER. PRIMEVIGILANCE DID REACH OUT TO OBTAIN WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    MATERIAL NO.: 930815, BATCH NO.: UNKNOWN. IT WAS REPORTED SEVERE SKIN RASH/DERMATITIS AND PUSTULES REQUIRING STEROIDS FOR RESOLUTION WITH RASH OCCURING 2 WEEK POST OP. DR. [OMITTED] IS A BREAST SURGEON IN INDIANAPOLIS. SHE STATES THAT STARTING IN DECEMBER 80% OF HER BREAST RECONSTRUCTION PATIENTS HAVE HAD SEVERE SKIN REACTIONS TO WHAT SHE BELIEVES IS CHLORAPREP. INCIDENTS ARE OCCURRING ON PATIENTS FROM THE ASC AND THE MAIN HOSPITAL. HOWEVER SHE DOES NOT WORK AS FREQUENTLY AT THE HOSPITAL. DR. [OMITTED] PERFORMS 2-4 BREAST RECONSTRUCTIONS PER WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81471 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