BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMEND FOSAPREPITANT

    MDR report key: 11817301 · Received May 12, 2021

    Report

    Report Number
    MW5101320
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    DR. REDDYS
    Product Code
    KYW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT IN CHEMO TODAY FOR CYCLE 1 DAY 1 OF OXALIPLATIN. SHE DEVELOPED FLUSHING AND SOB WITHIN 2-3 MINUTES OF THE EMEND BEING STARTED. EMEND WAS STOPPED AND OVER THE NEXT 5-8 MINUTES ALL OF HER SYMPTOMS RESOLVED. WHEN THE REACTION STARTED BP AND HR WAS ELEVATED. SEVERAL MINUTES AFTER THE EMEND WAS STOPPED BP WAS 117/62 AND HR 57 WITH OXYGEN SAT 110% ON RA. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706811 EMEND FOSAPREPITANT CONTAINER, LIQUID MEDICATION, GRADUATED KYW DR. REDDYS CSA06001A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other