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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Patient had mesh placed to an intra-peritoneal location with poor results.Complications not listed.

Event Description

N/a.

Manufacturer Narrative

Analysis - no complications were listed and there was no lot number or part number provided therefore an investigation cannot be performed.Summary/conclusion - based on the details provided there is not enough evidence to conclude that there was an issue with an atrium medical mesh product.Clinical evaluation - it was reported that the patient had a mesh implant during an intraperitoneal onlay mesh procedure (ipom).C-qur mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds or chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.The instructions for use (ifu) states adequate mesh fixation is required to minimize post-operative complications and recurrence.The fixation technique, method, and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes.The ifu also states it is important to orient c-qur mesh correctly to prevent recurrence.The absorbable coating is located on the polypropylene monofilaments of the mesh and is not a tissue separating layer.Avoid direct contact with the viscera (intestines) to minimize the possibility of adhesions.Do not use a c-qur mesh in patients where tissue separation is of particular concern.Complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera (intestines) and other organs.The patient should be advised to contact the physician should an adverse reaction occur.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7846619
• MDR Text Key: 119242100
• Report Number: 3011175548-2018-00972
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

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
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention