BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 13433037 · Received February 2, 2022

    Report

    Report Number
    3004932373-2022-00029
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 21, 2022
    Report Date
    January 26, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    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: 930815 , BATCH NO: UNKNOWN. IT WAS REPORTED THAT PATIENTS DEVELOPED BURN-LIKE INJURIES TO THEIR OPERATIVE UPPER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47837 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