MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COSEAL; SEALANT, POLYMERIZING

Catalog Number 934070

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

A2: age at time of event: newborn.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a newborn experienced an unspecified infection after undergoing heart surgery ¿single ventricle case¿ in which coseal was used.The physician reported the infection occurred ¿while spraying coseal¿.The cause of the event was not reported.It was not reported if there was any medical intervention.No further detail was provided regarding treatment if hospitalization was required or the patient outcome.No additional information is available.

Manufacturer Narrative

H10: 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.

• Brand Name: COSEAL
• Type of Device: SEALANT, POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16891427
• MDR Text Key: 314784454
• Report Number: 1416980-2023-02219
• Device Sequence Number: 1
• Product Code: NBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 934070
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other