BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 12930301 · Received December 3, 2021

    Report

    Report Number
    3004932373-2021-00517
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 4, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 0

    MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT REACTION TO CHLORHEXIDINE. DOIN: 22-NOV-2021. REFERENCE DETAIL: TREATMENT OF HEARTMATE III¿LVAD DRIVELINE INFECTION BY NEGATIVE PRESSURE WOUND THERAPY: RESULT OF OUR CASE SERIES CIKIRIKCIOGLU M., PONCHANT K., MURITH N., MEYER P., YILMAZ N., HUBER C. INTERNATIONAL JOURNAL OF ARTIFICIAL ORGANS (2021) 44:11 (912-916). DATE OF PUBLICATION: 1 NOV 2021 THE MINNEAPOLIS VETERANS AFFAIRS MEDICAL CENTER (VAMC) SUBCOMMITTEE ON HUMAN STUDIES APPROVED THIS STUDY. NACDG GUIDELINES OF PATCH TESTING ARE OUTLINED ELSEWHERE. 4 PATIENTS TESTED BY THE NACDG WITH OCCUPATIONS OF MUSICIAN/COMPOSER, MUSIC TEACHER, MUSIC STORE WORKER, OR MUSICAL INSTRUMENT/CAMERA/WATCH REPAIRER COMPRISED THE MP GROUP. DEMOGRAPHICS, ALLERGENS, REACTION CHARACTERISTICS, CLINICAL RELEVANCE, AND SOURCE DETAILS WERE INVESTIGATED USING DESCRIPTIVE ANALYSES. OCCUPATIONALLY RELATED: ALLERGENS INCLUDED EPOXY (N = 1), PCMX (4-CHLORO-3,5-XYLENOL) (N = 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820087 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other