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 Problem Unspecified Infection (1930)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported seprafilm was used in rectal cancer surgery in a patient who developed enteritis.On day after performing laparoscopic rectal resection/amputation (low anterior resection) or surgical support for rectal cancer, the physician noticed swelling on the patient¿s right lower leg, resulting from internal pressure in the right tibialis longus muscle area.The event of swelling on the patient¿s right lower leg was caused by an unrelated event distinct to the seprafilm¿s area of placement.The presentation of enteritis in relation to device placement is unknown.It was not reported if the patient was treated for enteritis.The patient¿s outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: h6 and h10.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, ABSORABLE, ADHESION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SANOFI GENZYME; 11 forbes rd.; attn: receiving department; northborough MA 01532
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17986836
• MDR Text Key: 326292456
• Report Number: 1416980-2023-05401
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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: CBYSEP040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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
• Treatment: NI.
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Male