BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATH TEK FOR H. PYLORI

    MDR report key: 8231369 · Received January 8, 2019

    Report

    Report Number
    MW5082969
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    December 28, 2018
    Manufacturer
    OTSUKA AMERICA PHARMACEUTICAL INC.
    Product Code
    OZA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER WENT INTO (B)(6) HEALTH CLINIC TO GET A REFERRAL FOR A GASTROENTEROLOGIST AND THEY GAVE HER BREATH TEK TO TAKE TO FIND OUT IF SHE HAD H. PYLORI. SHE PASSED OUT AND THAT NIGHT VOMITED 4 TIMES. DURATION OF ADVERSE EVENT: 8 HRS. (FAINTED) WITHIN 20 MINS. DIAGNOSIS OR REASON FOR USE (INDICATION): MY DAUGHTER DID NOT REQUEST THIS TEST. THEY JUST TOLD HER TO DRINK IT. SHE WAS NOT TOLD AHEAD OF THE TIME THAT THERE WOULD BE ANY ADVERSE REACTIONS. THIS NEEDS TO BE INVESTIGATED. DATES OF USE: (B)(6) 2018. DURATION OF USE: 1 MINUTE(S), FREQUENCY OF CONSUMPTION: 1 DAY(S), AMOUNT CONSUMED PER SERVING: 8 OZ, ADMINISTRATION ROUTE: ORAL. INGREDIENT NAME: PRANACTIN-CITRIC; INGREDIENT AMOUNT: 8 OZ. HL7 BATCH CONTROL INFO - SUBMITTING ORGANIZATION ID: SRPCIT. HL7 BATCH RECEIVER INFO: BATCH RECEIVER (ROOT) USFDA; BATCH RECEIVER (EXTENSION) US FOOD AND DRUG ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17932 BREATH TEK FOR H. PYLORI TEST UREA ADULT AND PEDIATRIC (BREATH) OZA OTSUKA AMERICA PHARMACEUTICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening