InjuryOZA
UREA WITH CITRIC ACID BREAST TEST
Received Jul 19, 2021 · Event occurred Jul 14, 2021
Report MW5102628 · MDR key 12195952
Device
Generic name
Test, Urea Adult And Pediatric (breath)
Manufacturer
UnkProduct problems
- Patient Device Interaction Problem
Patient
16 YR
- Abdominal Pain
- Hypersensitivity/Allergic reaction
- Muscle Weakness/Atrophy
- Nausea
- Vomiting
- Dizziness
- Presyncope
- Abdominal Pain
- Hypersensitivity/Allergic reaction
- Muscle Weakness/Atrophy
- Nausea
- Vomiting
- Dizziness
- Presyncope
Narrative
Description of Event or Problem
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).