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.

Manufacturer Narrative

Article reviewed: wang et al.2021.Large abdominal hernia repair with closed incision negative pressure therapy: a case series.J wound care; 30(3):192-196.This complaint is based on information found within an article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.Attempts to obtain the device lot information was conducted but unsuccessful.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.Conclusion: although surgical site infections were common after large incisional hernia repair, with an incidence in this patient population of 43%, 62% in control group compared with 32% in the cinpt treatment group, however considering the design of the study, non-significant reductions in wound infection, seroma and wound dehiscence and the fact that this study demonstrated a statistically significant decreased rate of return to or for hernia recurrence, one can infer that the atrium c-qur¿ polypropylene mesh performed as expected.The authors did not attribute occurred complication to any particular type of mesh.

Event Description

N/a.

• 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: lori gosselin ; 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention