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.
[55725643]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[55725644]
It was reported that a coseal had white particulate 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
[58202424]
Additional information: device evaluated by mfr? , evaluation codes. The actual device was not available; however, a retained sample was evaluated. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. The reported condition was not verified. 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 | 1416980-2016-15667 |
| MDR Report Key | 5980220 |
| 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 |
| Model Number | NA |
| Catalog Number | 934074 |
| Lot Number | HA151109 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |