MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-21 for COSEAL 934072 manufactured by Baxter Healthcare - Hayward.
[121433896]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[121433897]
A patient experienced an unspecified leak after undergoing a surgical procedure in which coseal was used? On the lungs?. The cause of the leak was unknown as the surgeon reported? They tested for leaks prior to closing and found none?. Subsequently,? The patient was taken back to surgery?. It was reported the patient was in stable condition. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[125158312]
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Per the coseal instructions for use (ifu) included in coseal kits sold in the us, coseal is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. Coseal is not indicated to be used on lungs in the us. The approved indication for use is listed in the ifu. This was a misuse of the coseal product; the surgeon used it outside the indication for use. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[125158313]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-06086 |
| MDR Report Key | 7899595 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-21 |
| Date of Report | 2018-10-24 |
| Date Mfgr Received | 2018-09-28 |
| Date Added to Maude | 2018-09-21 |
| 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 | 2018-09-21 |
| Model Number | NA |
| Catalog Number | 934072 |
| Lot Number | NI |
| 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 | 1. Required No Informationntervention | 2018-09-21 |