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 Abdominal Pain (1685); Vomiting (2144)

Event Date 09/14/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced post-operative ileus after undergoing laparoscopic rectal sphincter resection and ileostomy surgery using the product seprafilm.Two days after the surgery, the patient presented stomach discomfort and vomiting.The next day, imaging showed decreased intestinal motility, however stoma drainage was good.Two days later, the caliber change was near the stoma, the physician diagnosed ileus, and a stoma balloon was placed.Six days later, it was noted that imaging confirmed improvement and good defecation using a stoma.Twelve days later, the patient was discharged from the hospital and without recurrence of ileus.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, 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: 17957193
• MDR Text Key: 325941262
• Report Number: 1416980-2023-05287
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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: BBYSEP069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female