BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12624416 · Received October 13, 2021

    Report

    Report Number
    3004932373-2021-00465
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 13, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE ATRIUM MAIN HOSPITAL. 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 THAT A GYN SURGEON WHO IS REQUESTING TO SPEAK WITH BD REGARDING SKIN RASHES/BURNS AFTER USING CHLORAPREP. VERBATIM: HELLO /OMIT/, MI WILL FOLLOW-UP DIRECTLY WITH YOUR PHYSICIAN AND OFFER TROUBLESHOOTING TIPS. PLEASE ENSURE YOU HAVE FILED THE COMPLAINT PER BD POLICY AS YOU WERE NOTIFIED OF HER CONCERNS ABOUT CHLORAPREP CAUSING "SKIN RASHES/BURNS". I HAVE INCLUDED THEM ON THIS EMAIL BUT PLEASE EXCUSE ANY DUPLICATE WORK THIS MAY HAVE CAUSED IF YOU HAD SUBMITTED IT ALREADY. INITIAL REPORTER: I HAVE A GYN SURGEON WHO IS REQUESTING TO SPEAK WITH YOU REGARDING SKIN RASHES/BURNS AFTER USING CHLORAPREP. SHE IS AWARE OF THE 2-3% RATE FOR ALLERGIC REACTION BUT IS STILL CONCERNED ABOUT USING CHLORAPREP. SHE CHANGED HER METHODS TO USING THE 10.5ML FOR THE NAVAL BUT USES BETADINE FOR THE REST OF THE PREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522832 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other