MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-07-03 for UBIT (13C-UREA) manufactured by Otsuka America Pharmaceutical Inc..
[3698187]
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.
Patient Sequence No: 1, Text Type: D, B5
[10905345]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2013-00001 |
| MDR Report Key | 3216740 |
| Report Source | 01,05 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-07-02 |
| Date Mfgr Received | 2013-06-11 |
| Date Added to Maude | 2014-08-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1 UNIVERSITY SQUARE DR., SUITE 500 |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer G1 | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UBIT (13C-UREA) |
| Generic Name | UBIT (13C-UREA) |
| Product Code | MSQ |
| Date Received | 2013-07-03 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Manufacturer Address | 2440 RESEARCH BLVD. ROCKVILLE MD 20850000 US 20850 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-03 |