MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC

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

Patient Problems Wound Dehiscence (1154); Seroma (2069); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Article received: wang, e. E. (2021). Large abdominal hernia repair with closed incision negative pressure therapy: a case series. Journal of wound care, 192-196. Purpose: this study assesses the wound outcomes for hernia repair patients receiving closed incision negative pressure therapy (cinpt). Method: a six-year retrospective case series of patients who had undergone large abdominal incisional hernia repair wounds treated with cinpt was conducted. Conclusion: cinpt, when used after large abdominal incisional hernia repair, may help in the prevention of wound complications. Per the article adverse events included: surgical site infection, seroma, dehiscence and recurrence.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: dorota wolpiuk ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12045604
• MDR Text Key: 262400114
• Report Number: 3011175548-2021-00692
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/22/2021 Patient Sequence Number: 1