BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 12572101 · Received October 4, 2021

    Report

    Report Number
    3004932373-2021-00458
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 28, 2021
    Report Date
    February 25, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP EMDR FOR (B)(4) REFLECTS PATIENT IDENTIFIER INFORMATION UPDATE . BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE.

    Description of Event or Problem · 0

    MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. IT WAS REPORTED THAT APPLICATION SITE STINGING, SITE BURNING. VERBATIM: IT WAS REPORTED THAT APPLICATION SITE STINGING, SITE BURNING THE PATIENT'S CONCOMITANT MEDICATION DETAILS WERE NOT PROVIDED. ON (B)(6) 2021, THE PATIENT WAS PREPPED WITH CUTANEOUS CHLORAPREP (CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL) SOLUTION AT A DOSE OF 1 DOSAGE FORM TOTAL, FOR SKIN DISINFECTION. THE BATCH NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. ON THE SAME DATE, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF APPLICATION SITE BURNING AND STINGING. AT THE TIME OF THE REPORT, THE PATIENT RECOVERED FROM THE EVENT OF APPLICATION SITE BURNING AND STINGING. THE REPORTER DID NOT PROVIDE SERIOUSNESS AND CAUSALITY ASSESSMENT BETWEEN THE ADMINISTRATION OF CHLORAPREP AND THE REPORTED EVENT OF APPLICATION SITE BURNING AND STINGING. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (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: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT APPLICATION SITE STINGING, SITE BURNING. VERBATIM: IT WAS REPORTED THAT APPLICATION SITE STINGING, SITE BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471370 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other