BREATHTEK (UBT)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-28 for BREATHTEK (UBT) manufactured by .

Event Text Entries

[2056668] Event verbatim [lower level term]. Anaphylactic reaction [anaphylactic reaction] case description: a healthcare professional reported that a (b)(6) male patient experienced an anaphylactic reaction. The event occurred while on breathtek (ubt) 13c-urea. On (b)(6) 2011, 30 minutes after office staff administered the breathtek test, the pt ate some shrimp. On (b)(6) 2011, two hours after the administration of the breathtek test and one and one-half hours after eating the shrimp, the patient had an anaphylactic reaction. The patient was taken to the emergency room where he was administered an unknown steroid and epinephrine. It is unknown if any laboratory tests were performed. The patient's relevant medical history includes no known allergies. The patient's concomitant medications and past drug history are unknown. The outcome of the event is recovered. Follow-up received: telephone communication with dr (b)(6) indicated that the patient saw an allergist who stated that he had anaphylactoid reaction, which could have been caused by the mannitol in the pranactin citric. He was negative initially for food allergies, but he will go back for another skin test for food allergies in three weeks to rule out a false negative. Follow-up received: the patient stated that he came home after the breathtek test and consumed shrimp. Twenty minutes later, the patient noticed itching in his hands with red palms which progressed to tingling and numbness in his lips. Soon after he noticed his face was swollen with hives on his neck. The patient's voice became hoarse and he experienced trouble breathing and felt that his throat was closing. The patient drove himself to the hospital and was given injections of epinephrine, steroids and diphenhydramine. After a couple of hours of observation, the hives resolved, but the patient was still swollen. The patient was admitted to the hospital and was treated with a medrol dose pack, diphenhydramine, famotidine a duoneb nebulizer and bismuth subsalicylate. The patient was discharged from the hospital on (b)(6) 2011 with diphenhydramine and epinephrine pens in case of another reaction; however, he was still swollen. The swelling resolved on (b)(6) 2011. The patient has not experienced another reaction and has had no other symptoms. On (b)(6) 2011, he saw an allergist who tested him for shrimp and sesame seed food allergies which all came up negative.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3000718406-2011-00001
MDR Report Key2118983
Report Source05
Date Received2011-04-28
Date of Report2011-03-30
Date of Event2011-03-15
Date Mfgr Received2011-03-30
Date Added to Maude2011-07-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street2-9 KANDA TSUKASA-MACHI CHIYODA-KU
Manufacturer CityTOKYO 101-8535
Manufacturer CountryJA
Manufacturer Postal101-8535
Manufacturer G1OTSUKA AMERICA PHARMACEUTICALS INC.
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBREATHTEK (UBT)
Generic NameNONE
Product CodeMSQ
Date Received2011-04-28
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-04-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.