MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2012-05-30 for BREATHTEK manufactured by Otsuka Pharmaceutical.
[2740684]
Swollen hands [swelling of hands]. Burning sensation in throat [throat burning sensation of]. Itching all over [itching all over]. Sensitive tongue [sensitive tongue]. Itching hands [itching both hands]. Throat was closing [throat swelling]. Case description: a pt was administered pranactin-citric solution, once, on (b)(6) 2010, to complete the breathtek tests for h pylori. On (b)(6) 2010, almost immediately after taking the pranactin-citric solution the pt has a burning sensation in her throat and red splotches on her tongue. On (b)(6) 2010, later that night, the pt felt like her throat was closing and that she began to itch all over. On (b)(6) 2010, the pt's throat was still burning, the back of her hands were swollen and she was itching all over. As of (b)(6) 2010, the nurse practitioner stated that she could see that the pt's throat was red and irritated down the posterior and that she was going to prescribe steroids to help with the swelling and itching. It is unknown if the pt plans to take another breathtek test. Diagnosis for use: helicobacter pylori identification test (helicobacter pylori identification test).
Patient Sequence No: 1, Text Type: D, B5
[9826520]
Follow up received: the subject experienced swollen hands and stated that it hurt to swallow and her throat felt swollen with a sensitive tongue. It was noted she had no symptoms prior. She was treated in the clinic with a medrol dose pack and diphenhydramine, the site followed up with the pt a month later and the symptoms had resolved. Follow up received: it was determined by the site that since the subject was not seen or treated at the clinic for this event, they were not comfortable making the diagnosis of an allergic reaction. Otsuka conducted a retrospective medical review of case narratives following a new globally harmonized procedure of case assessment. As a result of this review, pharyngeal oedema (serious), pruritus generalized and glossodynia were additionally picked up from the narrative and entered as an adverse event into the pv database.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2012-00001 |
| MDR Report Key | 2602796 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2012-05-30 |
| Date of Report | 2017-10-24 |
| Date of Event | 2010-03-24 |
| Date Mfgr Received | 2017-10-24 |
| Date Added to Maude | 2012-06-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MIRZA RAHMAN |
| Manufacturer Street | 508 CARNEGIE CENTER DRIVE SUITE 500 |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer G1 | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK |
| Generic Name | TEST, UREA (BREATH OR BLOOD) |
| Product Code | MSQ |
| Date Received | 2012-05-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA PHARMACEUTICAL |
| Manufacturer Address | 508 CARNEGIE CENTER DRIVE PRINCETON 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-30 |