MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for BREATH TEK FOR H. PYLORI manufactured by Otsuka America Pharmaceutical Inc..
[132759554]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082969 |
| MDR Report Key | 8231369 |
| Date Received | 2019-01-08 |
| Date of Event | 2018-12-28 |
| Date Added to Maude | 2019-01-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREATH TEK FOR H. PYLORI |
| Generic Name | TEST UREA ADULT AND PEDIATRIC (BREATH) |
| Product Code | OZA |
| Date Received | 2019-01-08 |
| Device Expiration Date | 2018-12-28 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-01-08 |