MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-08-03 for UBIT (13C-UREA) TABLET, 100MG MILLIGRAM(S) manufactured by Otsuka America Pharmaceutical Inc..
[2732024]
Rash generalised [rash generalised]. Case description: this is a case of rash reported to drug info center at (b)(6) by a pharmacist. Follow-up info received: the reported event of rash was updated to generalised rash, and this case was upgraded to serious at the time of this report. On (b)(6) 2012, a pt with underlying acute gastritis experienced generalised rash on the day of start of ubit (13c-urea). The pt was in his (b)(6). At 0900 in the morning on (b)(6) 2012, the pt received 13c-urea 100 mg/day. In that early evening, he experienced rash and visited a nearby hospital. Rash (generalised) developed. Antiallergic agents and steroid ointment were prescribed at the nearby hospital and the rash (generalised) was resolving on an unk date. The pharmacist commented as follows: although situation of other medication use was unk, as per the physician, 13c-urea was suspected to be the cause. The prescribing physician commented as follows: the reason why the outcome was not "resolved" was because the pt had scratched due to strong itching. While the reporting physician reported the event as non-serious, the company judged it to be "medically significant. "
Patient Sequence No: 1, Text Type: D, B5
[10091200]
Reporter's causality assessment: the rash generalised was possibly related to 13c-urea.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2012-00003 |
| MDR Report Key | 2680871 |
| Report Source | 01,05 |
| Date Received | 2012-08-03 |
| Date of Report | 2012-06-21 |
| Date of Event | 2012-06-16 |
| Date Mfgr Received | 2012-06-21 |
| Date Added to Maude | 2012-08-07 |
| 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 DRIVE STE 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) TABLET, 100MG MILLIGRAM(S) |
| Generic Name | UBIT (13C-UREA) TABLET, 100MG MILLIGRAM(2) |
| Product Code | MSQ |
| Date Received | 2012-08-03 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-03 |