MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2012-06-11 for BREATHTEK manufactured by Otsuka Pharmaceutical.
[16729651]
Bronchospasm [bronchospasm]. Difficulty breathing [difficulty breathing]. Case description: this physician reported that a patient of unknown age and gender drank one pouch of pranactin-citric solution for the purpose of preparing for the breathtek test. The patient's relevant medical history, concomitant medications and relevant past drug history are unknown. On (b)(6) 2011, the patient experienced difficulty breathing 5 to 7 minutes after drinking the pranactin-citric solution. On (b)(6) 2011, the physician states the patient's difficulty breathing is better. It is unknown if there is any relevant laboratory data. As of (b)(6) 2011, it is unknown if the patient continues to use the pranactin-citric solution and the physician reported that the patient's difficulty breathing is better. The reporting physician requested a call back to gather further information for safety report. An outbound call was placed at 1002 on (b)(6) 2011 and a voicemail message was reached. Physician unavailable. Limited information available. Follow up information received on may 17, 2012: patient's credentials (initials, age and gender), medical history, suspect product details and concomitant medication were provided. The patient's medical history included reactive airway disease and hypertension. Concomitant medication included atacand for an unknown indication. On (b)(6) 2011, the patient received pranactin citric solution at a dose of 3 mg by mouth for abdominal pain and suspected h. Pylori. On (b)(6) 2011, the physician reported that bronchospasms began when the patient breathed into the collection bag to provide a breath sample. The patient was administered a bronchodilator and the bronchospasm improved upon observation. No relevant laboratory testing was performed. At the time of this report, treatment with pranactic citric solution was stopped and bronchospasm had resolved. The reporter did not confirm whether bronchospasm was due to pranactin citric solution or the coating inside the bag.
Patient Sequence No: 1, Text Type: D, B5
[17045047]
Reporter's causality assessment: the reporter did not provide the causality. Otsuka's causality assessment: otsuka assessed the event as related to pranactin citric.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2012-00002 |
| MDR Report Key | 2621330 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2012-06-11 |
| Date of Report | 2017-11-01 |
| Date of Event | 2011-08-24 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2012-08-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR MIRZA RAHMAN |
| Manufacturer Street | 508 CARNEGIE CENTER DRIVE SUITE 500 |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer G1 | OTSUKA AMERICA PHARMACEUTICAL INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK |
| Generic Name | UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE |
| Product Code | MSQ |
| Date Received | 2012-06-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA PHARMACEUTICAL |
| Manufacturer Address | 508 CARNEGIE CENTER PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-06-11 |