MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-09-27 for COSEAL 934074 manufactured by Baxter Healthcare - Hayward.
[55702067]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[55702068]
It was reported that a coseal had white matter on the joiner base. This was observed before use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[58144758]
The device was received for evaluation. Visual inspection with naked eye identified white particulate matter in the dsd pouches. Spectroscopic evaluation determined the pm are consistent with leaking of solution from the transfer accessory junction followed by evaporation and subsequent precipitation. The reported condition was verified. The cause of the condition could not be determined. A nonconformance has been opened to address this issue. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2016-15647 |
| MDR Report Key | 5979686 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-27 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-08-29 |
| Date Mfgr Received | 2016-10-14 |
| Date Added to Maude | 2016-09-27 |
| 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 | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Street | 2024 W WINTON AVE |
| Manufacturer City | HAYWARD CA 94545 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COSEAL |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2016-09-27 |
| Returned To Mfg | 2016-10-14 |
| Model Number | NA |
| Catalog Number | 934074 |
| Lot Number | HA151109 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Address | HAYWARD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-27 |