UBIT (13C-UREA)

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.