MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-01-17 for BREATHTEK UBT COLLECTION KIT 8207 manufactured by Meretek Diagnostics, Inc..
[3210320]
A few minutes after the pt drank the pranactin citric drug solution as part of the breathtek ubt h. Pylori test, she reported discomfort and numbness in limbs, she was flushed and was having heart palpitations, and was feeling anxious, the back of her felt hot and cold overall.
Patient Sequence No: 1, Text Type: D, B5
[10465745]
Manufacturing background info. Meretek contracts out the manufacture of the breathtek ubt collection kit, which occurs in three separate phases: phase 1 - manufacture of the bulk granulated pranactin -citric drug component. This part of the manufacture is performed by vps corporation. Phase ii - packaging the bulk pranactin citric drug component into pouches. This part of the manufacture is performed by cardinal health. Phase iii - assembly of the kit components into the breathtek ubt collection kit. This assembly is performed by heritage labs international, llc. The finished breathtek ubt collection kits are distributed by (b)(4) to meretek diagnostics, inc. Clients.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1060925-2007-00002 |
| MDR Report Key | 2894830 |
| Report Source | 05 |
| Date Received | 2007-01-17 |
| Date of Report | 2007-01-16 |
| Date of Event | 2007-01-11 |
| Date Facility Aware | 2007-01-11 |
| Report Date | 2007-01-17 |
| Date Reported to FDA | 2007-01-17 |
| Date Reported to Mfgr | 2007-01-17 |
| Date Mfgr Received | 2007-01-11 |
| Date Added to Maude | 2013-01-10 |
| 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 Street | 2655 CRESCENT DRIVE, SUITE C |
| Manufacturer City | LAFAYETTE CO 800263372 |
| Manufacturer Country | US |
| Manufacturer Postal | 800263372 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK UBT COLLECTION KIT |
| Generic Name | BREATHTEK UBT COLLECTION KIT |
| Product Code | MSQ |
| Date Received | 2007-01-17 |
| Model Number | NA |
| Catalog Number | 8207 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERETEK DIAGNOSTICS, INC. |
| Manufacturer Address | LAFAYETTE CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2007-01-17 |