MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SEPRAFILM; BARRIER, ABSORABLE, ADHESION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

It was reported that the product seprafilm was used on a patient undergoing a caesarean section.Following surgery, on the front of the uterus, a seroma was observed.Some leakage fluid was observed only in the area of application of seprafilm.The patient received antibiotic treatment for this event.It was not reported if the patient was hospitalized for this event.The patient¿s 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

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): 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: 18012786
• MDR Text Key: 326629164
• Report Number: 1416980-2023-05491
• Device Sequence Number: 1
• Product Code: MCN
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female