FDA Adverse Event
Injury
Summary report: N
BREATHTEK (UBT)
MDR report key: 1400209
·
Received May 28, 2009
Report
- Report Number
- 3000718406-2009-00001
- Event Type
- Injury
- Date Received
- May 28, 2009
- Date of Event
- April 28, 2009
- Report Date
- May 28, 2009
- Manufacturer
- OTSUKA AMERICA PHARMACEUTICAL COMPANY, INC. (OAPI)
- Product Code
- MSQ
- PMA / PMN Number
- K014225
- Removal / Correction Number
- NONE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NONE.
Description of Event or Problem · 1
FELT ILL 'MALAISE'. CASE DESCRIPTION: IN 2009, A PATIENT FELT ILL AFTER INGESTING THE PRANACTIN-CITRIC SOLUTION OF THE BREATHTEK KIT FOR DETECTION OF HELICOBACTER PYLORI. THE SUBJECT STATED SHE FELT FAINT 2-3 MINUTES AFTER DRINKING THE PRANACTIN-CITRIC SOLUTION. SHE WAS DIAPHORETIC AND PALE AND STATED THAT HER "STOMACH, ARMS, AND LEGS FELT LIKE THEY WERE ON FIRE". THE PATIENT'S LEGS WERE ELEVATED AND A COLD CLOTH WAS PLACED ON HER HEAD AND SHE WAS TAKEN TO THE HOSPITAL. THE PATIENT'S VITAL SIGNS WERE REPORTED TO BE NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREATHTEK (UBT) | NONE | MSQ | OTSUKA AMERICA PHARMACEUTICAL COMPANY, INC. (OAPI) | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization |