MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SEPRAFILM; BARRIER, ABSORABLE, ADHESION

Catalog Number 38005

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

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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 underwent a gynecological tumor resection surgery in which seprafilm was used on the pelvic floor.Four to five days following the surgery, the patient developed a fever and intraperitoneal infection.Antibiotics were administered, and the intraperitoneal infectious material passed vaginally.Several days later, the infection subsided, and the patient was discharged from the hospital.No additional information is available.

• Brand Name: SEPRAFILM
• Type of Device: BARRIER, ABSORABLE, ADHESION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): GENZYME CORPORATION; 51 and 74-80 new york avenue; framingham MA 01701
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16404342
• MDR Text Key: 309857313
• Report Number: 1416980-2023-00565
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 38005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/20/2023
• 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): Required Intervention
• Patient Sex: Female