BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UREA WITH CITRIC ACID BREAST TEST

    MDR report key: 12195952 · Received July 19, 2021

    Report

    Report Number
    MW5102628
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 14, 2021
    Manufacturer
    UNK
    Product Code
    OZA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALLERGIC REACTION; WAS GIVEN UREA WITH CITRIC ACID AS PART OF AN ULCER BREATHE TEST. ONCE SHE SWALLOWED THE SUBSTANCE, IMMEDIATELY BEGAN FEELING DIZZY AND FAINT. STOMACH PAINS, NAUSEA, AND VOMITING. FEELING GENERALLY VERY WEAK AND UNABLE TO DO MUCH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084410 UREA WITH CITRIC ACID BREAST TEST TEST, UREA ADULT AND PEDIATRIC (BREATH) OZA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other