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

Catalog Number 934070

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

Patient Problems Adhesion(s) (1695); Vomiting (2144); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

It was reported that a patient experienced a small bowel obstruction due to adhesion formation after undergoing open myomectomy surgery in which coseal was used on the suture line.The cause of the adhesion formation was not reported.It was reported that after suturing the patient¿s uterus, the surgeon dripped two milliliters of coseal on the suture line using a seven centimeter coseal applicator.There were no issues noted with the product during use.The patient was discharged from the hospital (date unspecified).On the second day post-operatively, the patient experienced vomiting.Three days later, the patient returned to the hospital and was diagnosed with small bowel obstruction.Ten days post-op the patient underwent a second surgery to treat the obstruction.During the revision surgery, it was determined that the obstruction was caused by adhesion formation with a hardened opaque substance (not further specified) between the suture line and the small bowel.At the time of this report, the patient was recovered from the event and was discharged from the hospital.No additional information is available.

Manufacturer Narrative

(b)(4).The second surgery was performed on an unknown date reported as ¿last week¿.(b)(6).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 - 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: 4866664
• MDR Text Key: 6059959
• Report Number: 1416980-2015-26562
• Device Sequence Number: 1
• Product Code: NBE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P030039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 934070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR