MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SEPRAFIM; BARRIER, ABSORBABLE, ADHESION

Catalog Number 664103

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

Patient Problem Peritonitis (2252)

Event Date 12/21/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a laparotomy with stoma reversal in which seprafim was used.The seprafim was placed on the intestinal loops (all four quadrants).Three days following surgery, the patient was diagnosed with peritonitis.It was not reported if the patient was hospitalized for the event.The patient received unspecified antibiotic therapy for the event.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

E1: initial reporter postal code: (b)(6).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: SEPRAFIM
• Type of Device: BARRIER, ABSORBABLE, 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: 17062724
• MDR Text Key: 316568574
• Report Number: 1416980-2023-02726
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 05413765588310
• UDI-Public: (01)05413765588310
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Other
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Catalogue Number: 664103
• Device Lot Number: ABYSEP006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2023
• Date Device Manufactured: 02/23/2023
• 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: 3 MO