BEUDAMED
    FDA Adverse Event Summary report: N

    UBIT (13C-UREA)

    MDR report key: 3216740 · Received July 3, 2013

    Report

    Report Number
    3000718406-2013-00001
    Date Received
    July 3, 2013
    Report Date
    July 2, 2013
    Manufacturer
    OTSUKA AMERICA PHARMACEUTICAL INC.
    Product Code
    MSQ
    PMA / PMN Number
    K014225
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE REPORTING NURSE DID NOT PROVIDE SERIOUSNESS ASSESSMENT OF THE EVENT, THE COMPANY JUDGED IT TO BE "MEDICALLY SIGNIFICANT". REPORTER CAUSALITY ASSESSMENT: NOT PROVIDED FOR THE EVENT OF CONSCIOUSNESS DISTURBED.

    Description of Event or Problem · 1

    CONSCIOUSNESS DISTURBED (ALTERED STATE OF CONSCIOUSNESS). CASE DESCRIPTION: THIS IS A CASE OF NON-SERIOUS FUZZY HEAD REPORTED TO DRUG INFO CENTER AT (B)(6)BY A NURSE. THIS CASE HAS ONLY LIMITED INFO FOR A COMPLETE MEDICAL ASSESSMENT. (B)(6) WILL MAKE EFFORTS TO FOLLOW UP THIS CASE. ON AN UNK DATE, A PT STARTED ON UBIT (13C-UREA) AT AN UNK DOSE. THE PT COMPLAINED OF FUZZY HEAD WHEN RETURNING HOME AFTER UREA BREATH TESTING (UBT). THE OUTCOME OF FUZZY HEAD WAS UNK. REPORTER CAUSALITY ASSESSMENT: NOT PROVIDED FOR THE EVENT OF FUZZY HEAD. FOLLOW-UP INFO RECEIVED ON (B)(6) 2013: FOLLOW-UP INFO WAS RECEIVED FROM THE REPORTING NURSE, WHO PROVIDED ADDITIONAL INFO REGARDING THE PT'S GENDER. THE REPORTED EVENT OF FUZZY HEAD WAS UPDATED TO DISTURBED CONSCIOUSNESS BY THE REPORTING NURSE SERIOUS AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306642 UBIT (13C-UREA) UBIT (13C-UREA) MSQ OTSUKA AMERICA PHARMACEUTICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other