MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-13 for COSEAL manufactured by Baxter Healthcare - Vienna.
[47230931]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[47230932]
It was reported that a coseal premix was yellowish, cloudy, and appeared to contain particles. The solution could then not be pushed through the applicator. This occurred during application of the solution. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[49133691]
(b)(4). Additional information: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2016-10617 |
| MDR Report Key | 5720353 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-13 |
| Date of Report | 2016-07-08 |
| Date Mfgr Received | 2016-07-06 |
| Date Added to Maude | 2016-06-13 |
| 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 | KINGA ALMASAN |
| 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 - VIENNA |
| Manufacturer Street | INDUSTRIESTRASSE 67 |
| Manufacturer City | VIENNA 1220 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 1220 |
| 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 | 2016-06-13 |
| 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 - VIENNA |
| Manufacturer Address | INDUSTRIESTRASSE 67 VIENNA 1220 AU 1220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-13 |