BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 11723909 · Received April 26, 2021

    Report

    Report Number
    3004932373-2021-00213
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 14, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY 3M. PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION 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

    IT WAS REPORTED MULTIPLE PATIENTS EXPERIENCING SKIN RASHES, BLISTERS AND ITCHING WHILE USING THE CHLORAPREP. PER PHONE CALL: I RECEIVED A PHONE CALL THIS MORNING FROM JULIE AT 3M IN REGARDS TO MULTIPLE PATIENTS EXPERIENCING SKIN RASHES, BLISTERS AND ITCHING WHILE USING THE CHLORAPREP. SYMPTOMS WERE TREATED WITH CORTISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624047 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other