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 Post Operative Wound Infection (2446)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent an internal anal sphincterotomy and ileostomy in which seprafilm was used.The following day, bloody drainage was observed from the midline wound.The next day drainage was performed under ct guidance, and there was pale blood drainage, so a drain was placed.Antibiotics piperacillin and tazobactam were started, and a wound infection was diagnosed.A day later the fever subsided and eating resumed.Three days later, the fever (36 degrees c) and wound infection improved, and the drain was removed.The next day, a fever developed (38 degrees c) and a small amount of fluid was observed below the abdominal wall of the left lower abdomen within the small mesentery on the pelvic floor.The following day, drainage was performed, and a trough value revealed drug-induced liver damage and decreased renal function.The antibiotic was continued, and abscess drainage was performed under ct guidance.Six days later the patient recovered.According to the physician the cause of the issue was dirt mixed in from the umbilicus.No additional information is available.

Manufacturer Narrative

Additional information: h4, h6 and h10.H4: device manufacture date: 07 oct 2022.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): 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: 18330057
• MDR Text Key: 330546864
• Report Number: 1416980-2023-06544
• 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: 02/01/2024

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: CBYSEP059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/01/2024
• Date Device Manufactured: 10/07/2022
• 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
• Treatment: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male