MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-05-31 for BREATHTEK (UBT) manufactured by .
[2015174]
Case description: a (b)(6) female consumer reported taking an unknown dose of the pranactin-citric (13c-urea) solution on (b)(6) 2011, for the purpose of completing the breathtek test to check for h. Pylori. The patient's medical history includes an "attack" or infection of h. Pylori in 2003. In (b)(6) 2011, her doctor drew blood two weeks prior to the breathtek test which showed a positive result. The patient's also has a history of hypertension. The patient's blood pressure was 135/75 when previously taking only one dose of toprol xl daily. In approximately 2003, the patient had an "attack" or infection of h. Pylori. In (b)(6) 2011, the patient's physician drew blood two weeks prior to the breathtek test which showed a positive result. The patient's relevant concomitant medications are unknown. In (b)(6) 2011, a week after taking the breathtek test, the patient's blood pressure "spiked" to 223/114. The patient's doctor increased the dosage of toprol xl to one in the morning and one in the evening. The patient's blood pressure went down to 175/80. As of (b)(6) 2011, the patient's blood pressure was still higher than prior to taking breathtek.
Patient Sequence No: 1, Text Type: D, B5
[9017839]
The patient declined further information for the safety report including follow-up, concomitant medications and provider information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2011-00002 |
| MDR Report Key | 2126486 |
| Report Source | 04 |
| Date Received | 2011-05-31 |
| Date of Report | 2011-05-31 |
| Date Mfgr Received | 2011-05-04 |
| Date Added to Maude | 2011-07-11 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2-9 KANDA TSUKASA-MACHI CHIYODA-KU |
| Manufacturer City | TOKYO 101-8535 |
| Manufacturer Country | JA |
| Manufacturer Postal | 101-8535 |
| Manufacturer G1 | OTSUKA AMERICA PHARMACEUTICALS INC. |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK (UBT) |
| Generic Name | NONE |
| Product Code | MSQ |
| Date Received | 2011-05-31 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-31 |