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 Adhesion(s) (1695)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a laparotomy in the middle and lower abdomen in which seprafilm was used for adhesion prevention, following resection and reconstruction of the rectum.It was reported 21 days post-operative, a relaparotomy was performed due to another indication.Strong adhesions were observed from the mid-lower abdomen to the small intestine in the pelvic cavity.As a result, the small intestine was completely resected except for the upper jejunum.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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 60073 ; 2242702068
• MDR Report Key: 17166572
• MDR Text Key: 317543533
• Report Number: 1416980-2023-03046
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 05413765588211
• UDI-Public: (01)05413765588211
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950034
• 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: 07/26/2023

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 Expiration Date: 05/14/2024
• Device Catalogue Number: 638005
• Device Lot Number: BBYSEP033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/26/2023
• Date Device Manufactured: 05/15/2021
• 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): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male