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

Catalog Number 638005

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

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

Event Date 06/15/2022

Event Type  Injury  

Event Description

A patient underwent a laparoscopic hysterectomy in which seprafilm was used.It was further reported the seprafilm was used on the peritoneal suture, on the right and left side of peritoneal opening.Subsequently, the patient developed a pelvic infection.At the time of this report, the patient outcome was not reported.No additional information is available.

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.

Manufacturer Narrative

B5: upon follow up it was reported seven days post-operative, the patient experienced a fever and presented to the hospital.The patient was admitted due to another indication.The same day, the patient was diagnosed with a pelvic infection.The patient was treated with maxipem (1 g, 2 times per day).Seven days after hospital admission, the patient was discharged and was recovered from the infection.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 16486632
• MDR Text Key: 310709102
• Report Number: 1416980-2023-00845
• 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,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 638005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• 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; Other
• Patient Age: 44 YR
• Patient Sex: Female