BREATH TEK FOR H. PYLORI
Received Jan 8, 2019 · Event occurred Dec 28, 2018
Report MW5082969 · MDR key 8231369
Device
Generic name
Test Urea Adult And Pediatric (breath)
Manufacturer
Otsuka America Pharmaceutical Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
19 YR
- Syncope
- Vomiting
- Syncope
- Vomiting
Narrative
Description of Event or Problem
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.