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 Abscess (1690); Fever (1858); Unspecified Infection (1930)

Event Date 10/25/2022

Event Type  Injury  

Event Description

A patient underwent a total laparoscopic hysterectomy in which seprafilm was used.Seprafilm was applied to pelvic floor and uterine stump sutures.Three days post-operative, the patient experienced a fever (37°c) and a pelvic infection was diagnosed.Minocycline (200 mg/day) was administered.Three days later, minocycline (200 mg/day) was changed to tazopipe (4.5g × 3/1 day) and chloramphenicol (vaginal tablet, 100 mg x 1/1 day) and miya bm (1 g x 3 times/day) were added.The following day, after a ct examination result, an abscess and ileus were diagnosed and fasting was started.The following day, a drain was inserted from the vagina and aspirated the abscess.Five days later, fasting was discontinued.Two days later, the drain was removed.The following day, the patient was discharged from the hospital.At the time of this report, the patient outcome was not reported.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, 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: 16672986
• MDR Text Key: 312593888
• Report Number: 1416980-2023-01510
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• 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
• Report Date: 04/04/2023

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 Catalogue Number: 638005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/04/2023
• 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
• Patient Age: 48 YR
• Patient Sex: Female