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

Catalog Number 934074

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

Patient Problems Bacterial Infection (1735); Inflammation (1932)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

A2: date of birth: (b)(6) 2022; a4: weight: 4659 grams; should additional relevant information become available, a supplemental report will be submitted.

Event Description

A tetralogy of fallot patient underwent a blalock-taussig shunting surgery in which coseal sealant was used.It was reported seven days post-operative the patient experienced mediastinitis.The patient was treated with vancomycin.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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: 17129276
• MDR Text Key: 317179616
• Report Number: 1416980-2023-02919
• Device Sequence Number: 1
• Product Code: NBE
• UDI-Device Identifier: 05413765000546
• UDI-Public: (01)05413765000546
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Catalogue Number: 934074
• Device Lot Number: HA220633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• 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
• Treatment: COSEAL SPRAY SET; EASYSPRAY
• Patient Outcome(s): Required Intervention
• Patient Sex: Male