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 2017-05-26 for COSEAL 934072 manufactured by Baxter Healthcare - Hayward.
[76123486]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[76123487]
A patient experienced and unspecified adverse event following a lung surgery in which coseal was used. The surgeon who applied the coseal with the easy spray device used excessive manual pressure, enough so that the entire product was expelled in approximately 3 seconds. No issues or defects were reported with the coseal or easy spray device and the product appeared to be fine at the application site. The following day the patient was taken back to surgery to clean out a clogged chest tube, at which time a small fragment of coseal was found within the tube. At the time of this report, the patient had recovered from the event. No additional information was available.
Patient Sequence No: 1, Text Type: D, B5
[78691154]
As the sample was not returned and the lot number is unknown, a device analysis cannot be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2017-04572 |
| MDR Report Key | 6596220 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-26 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-04-28 |
| Date Mfgr Received | 2017-06-09 |
| Date Added to Maude | 2017-05-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-05-26 |
| Model Number | NA |
| Catalog Number | 934072 |
| Lot Number | NI |
| 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 | 1. Required No Informationntervention | 2017-05-26 |