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

Catalog Number 430103

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 03/18/2024

Event Type  Injury  

Event Description

A premature neonatal patient (with congenital pathology) underwent a laparotomy for unknown reasons wherein seprafilm was applied.It was not reported where the seprafilm was applied.After an unspecified period of time, the surgical wound ¿does not heal and opens.¿ no further information was available at the time of this report.

Manufacturer Narrative

(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.

Manufacturer Narrative

H10: the actual device was not available; however, the device carton containing a sealed foil pouch and product insert were received for evaluation.Since the actual product was not able to be returned; a device analysis could not be completed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 19118899
• MDR Text Key: 340302526
• Report Number: 1416980-2024-01710
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PMA 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: 05/15/2024

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: 430103
• Device Lot Number: CBYSEP078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• 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
• Patient Outcome(s): Required Intervention