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

Catalog Number 934075

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Rash (2033); Tachycardia (2095)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

Complaint no: (b)(4).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.

Event Description

A patient experienced an anaphylactic reaction four minutes post application of coseal during a surgical procedure.The patient had undergone a bariatric procedure (removal of a lap band) in which coseal was used (no further detail was provided regarding the surgical technique).Subsequently, at the end of the surgical case during reversal of the general anesthesia (unspecified) with an unknown agent, the patient experienced tachycardia, a significant drop in blood pressure (not further specified), and a skin rash (location was not reported).The reaction occurred after surgical closure on wake up.The coseal was not removed.It was reported that adrenaline was administered (dose not reported) and the patient responded and was transferred to the intensive care unit with an uneventful recovery.No further information was provided regarding the patient's outcome from the event.No additional information is available.

• Brand Name: COSEAL
• Type of Device: SEALANT,POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer (Section G): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5934721
• MDR Text Key: 54138352
• Report Number: 1416980-2016-12502
• Device Sequence Number: 1
• Product Code: NBE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 934075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN ANESTHESIA REVERSAL AGENT
• Patient Outcome(s): Hospitalization; Required Intervention