InjuryMSQ
BREATHTEK (UBT)
Received May 28, 2009 · Event occurred Apr 28, 2009
Report 3000718406-2009-00001 · MDR key 1400209
Device
Product problems
- Use of Device Problem
Patient
48 YR
- Syncope
- Burning Sensation
- Malaise
- Diaphoresis
- Pallor
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
NONE.