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

Model Number	31328
Health Effect - Clinical Codes	Vomiting (2144); Obstruction/Occlusion (2422)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Dr used c-qur fx and patient started vomiting and checked into hospital.Doctor reported that there was bowel obstruction to the mesh.
Additional Manufacturer Narrative
Based on the details provided there is not enough evidence to conclude that the patient¿s bowel obstruction was caused by the mesh alone.It is likely that the mesh moved after the initial implantation strangulating the bowel.This would suggest that there is a possibility that the mesh was not secured properly during the initial implantation.A review of the device lot history records indicate that this lot of c-qur ¿fx mesh met all quality and performance requirements.Clinical evaluation: ventral hernias are hernias of the anterior abdominal wall and represent defects in the parietal abdominal wall fascia and muscle through which abdominal contents can protrude.C-qur fx is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.A small bowel obstruction occurs when your small or large intestine is blocked.Symptoms of a bowel obstruction include bloating, abdominal pain, nausea, vomiting, constipation, diarrhea, and abdominal cramps.Intestinal obstruction may also cause serious infection and inflammation of your abdominal cavity.The instructions for use (ifu) states 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 and other organs.The patient should be advised to contact the physician should an adverse reaction occur.

• Brand Name: C-QUR FX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7885360
• Report Number: 3011175548-2018-01022
• Device Sequence Number: 192391
• Product Code: FTL
• UDI-Device Identifier: 00650862313284
• UDI-Public: 00650862313284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K082748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2020
• Device Model Number: 31328
• Device Catalogue Number: 31328
• Device Lot Number: 423433
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 106