MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-28 for BREATHTEK (UBT) UNK manufactured by Otsuka America Pharmaceutical Company, Inc. (oapi).
[1198414]
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.
Patient Sequence No: 1, Text Type: D, B5
[8396184]
None.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2009-00001 |
| MDR Report Key | 1400209 |
| Report Source | 05 |
| Date Received | 2009-05-28 |
| Date of Report | 2009-05-28 |
| Date of Event | 2009-04-28 |
| Date Mfgr Received | 2009-04-29 |
| Date Added to Maude | 2009-06-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUVA ROY, PH.D., SR DIR |
| Manufacturer Street | 2440 RESEARCH BLVD. |
| Manufacturer City | ROCKVILLE MD 20850 |
| Manufacturer Country | US |
| Manufacturer Postal | 20850 |
| Manufacturer Phone | 2406833569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NONE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK (UBT) |
| Generic Name | NONE |
| Product Code | MSQ |
| Date Received | 2009-05-28 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA AMERICA PHARMACEUTICAL COMPANY, INC. (OAPI) |
| Manufacturer Address | ROCKVILLE MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-05-28 |