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

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Literature article: lee, k.And huang, j., ¿short-term post-operative outcomes between 4% icodextrin solution and hyaluronic acid-carboxylmethyl cellulose membrane during emergency caesarean section¿.Journal of clinical medicine (2019) 8, 1249; doi:10.3390/jcm8081249.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.

Event Description

A study was performed in which nine patients experienced post-operative incisional wound infections after undergoing emergency caesarean sections in which seprafilm was used.It was reported the seprafilm was placed over the anterior surface of the uterus, including the incisional site.Skin closure was performed using subcuticular sutures, and a sterile dressing was applied.Treatment for the incisional wound infections was not reported.No further details were provided regarding medical interventions or patient outcomes.No additional information is available.

• Brand Name: SEPRAFILM
• 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: 10567589
• MDR Text Key: 207951193
• Report Number: 1416980-2020-05892
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other