MAUDE Adverse Event Report: OTSUKA AMERICA PHARMACEUTICAL INC. BREATH TEK FOR H. PYLORI; TEST UREA ADULT AND PEDIATRIC (BREATH)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Vomiting (2144)

Event Date 12/28/2018

Event Type  Injury  

Event Description

My daughter went into (b)(6) health clinic to get a referral for a gastroenterologist and they gave her breath tek to take to find out if she had h.Pylori.She passed out and that night vomited 4 times.Duration of adverse event: 8 hrs.(fainted) within 20 mins.Diagnosis or reason for use (indication): my daughter did not request this test.They just told her to drink it.She was not told ahead of the time that there would be any adverse reactions.This needs to be investigated.Dates of use: (b)(6) 2018.Duration of use: 1 minute(s), frequency of consumption: 1 day(s), amount consumed per serving: 8 oz, administration route: oral.Ingredient name: pranactin-citric; ingredient amount: 8 oz.Hl7 batch control info - submitting organization id: srpcit.Hl7 batch receiver info: batch receiver (root) usfda; batch receiver (extension) us food and drug administration.

• Brand Name: BREATH TEK FOR H. PYLORI
• Type of Device: TEST UREA ADULT AND PEDIATRIC (BREATH)
• Manufacturer (Section D): OTSUKA AMERICA PHARMACEUTICAL INC.
• MDR Report Key: 8231369
• MDR Text Key: 132759554
• Report Number: MW5082969
• Device Sequence Number: 1
• Product Code: OZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 19 YR
• Patient Weight: 73