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

Catalog Number 638005

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

Patient Problem Peritonitis (2252)

Event Date 08/22/2021

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient underwent a surgery involving uterine fibroids and ovarian cysts in which seprafilm was used on a vaginal stump and a peritoneal defect.It was reported 11 days following surgery the patient experienced peritonitis.The cause of the event was reported as due to seprafilm.It was reported the patient ¿had to hospitalize longer than expected¿.Treatment for the event was not reported.Thirty-three days after the peritonitis diagnosis, the patient was recovered from the peritonitis event.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.

• Brand Name: SEPRAFILM
• Type of Device: BARRIER, ABSORBABLE, 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 ; 2242702068
• MDR Report Key: 12703987
• MDR Text Key: 278552948
• Report Number: 1416980-2021-06476
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): Y
• 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: 12/07/2021

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: 638005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/07/2021
• 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): Hospitalization
• Patient Sex: Female