BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 10423717 · Received August 18, 2020

    Report

    Report Number
    3004932373-2020-00002
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 18, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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).

    Description of Event or Problem · 1

    EVENT DESCRIPTION ; VERBATIM: ANAPHYLACTIC SHOCK; MEDDRA LLT ANAPHYLACTIC SHOCK, MEDDRA PT ANAPHYLACTIC SHOCK, SERIOUS. MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883295 UNKNOWN CHLORAPREP NOT SPECIFIED KXF CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other