MAUDE Adverse Event Report: UREA WITH CITRIC ACID BREAST TEST; TEST, UREA ADULT AND PEDIATRIC (BREATH)

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Dizziness (2194); Presyncope (4410)

Event Date 07/14/2021

Event Type  Injury  

Event Description

Allergic reaction; was given urea with citric acid as part of an ulcer breathe test.Once she swallowed the substance, immediately began feeling dizzy and faint.Stomach pains, nausea, and vomiting.Feeling generally very weak and unable to do much.Fda safety report id # (b)(4).

• Brand Name: UREA WITH CITRIC ACID BREAST TEST
• Type of Device: TEST, UREA ADULT AND PEDIATRIC (BREATH)
• MDR Report Key: 12195952
• MDR Text Key: 262645627
• Report Number: MW5102628
• Device Sequence Number: 1
• Product Code: OZA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 39