MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR V-PATCH MESH; MESH, SURGICAL, POLYMERIC

Model Number 31202

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

A full review of all manufacturing lot history and sterilization records was performed.All product met the product requirements and the product was properly sterilized.Clinical evaluation: a hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the abdominal muscles.The resulting bulge can be painful, especially when you cough, bend over or lift a heavy object.Atrium c-qur v-patch mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.An inguinal hernia is when tissue or intestines protrude through a weakened area of tissue in the area on either side of the pubic bone.A hernia doesn't improve on its own, however, and can lead to serious complications.Surgery is recommended to repair a hernia that is painful or enlarging.An umbilical hernia occurs when part of the intestine protrudes through the umbilical opening in the abdominal muscles.Umbilical hernias are common and typically harmless.They are most common in infants, but they can affect adults as well.During pregnancy, the umbilical cord passes through a small opening in the baby's abdominal muscles.The opening normally closes just after birth.If the muscles don't join together completely in the midline of the abdomen, this weakness in the abdominal wall may cause an umbilical hernia later in life.In adults, too much abdominal pressure can cause an umbilical hernia.Possible causes in adults include obesity, pregnancies, fluid in the abdominal cavity (ascites), previous abdominal surgery and chronic peritoneal dialysis.Any surgery that causes a break in the skin can lead to a postoperative infection.Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound.Any infection may cause redness, delayed healing, fever, pain, nausea, tenderness, warmth, or swelling.Other risks for infection include the compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes.Most infections can be treated successfully with antibiotic medications.Sometimes additional surgery or procedures may be required.Problems after hernia repair are usually related to using a mesh product that is too small or to the fixation method and technique.It may also be related to non-compliance with activity limitations post operatively.Other factors that contribute to the outcome of hernia repairs are the patient's weight and medical comorbidities such as morbid obesity, diabetes and a history of smoking.The instructions for use (ifu) warn do not cut or reshape c-qur v-patch mesh except for the polypropylene positioning straps as it could affect product performance and that excess material from the positioning straps located above the fixation points should be cut off and discarded.The ifu also states complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs.The ifu instructs: after surgical insertion, the reinforced mesh base of the c-qur v-patch mesh is to be secured in a flat condition completely covering the defect of the abdominal wall.Ensure that the entire reinforced mesh base remains flat against or along the defect during fixation to the abdominal wall.

Event Description

One month following repair of bilateral inguinal hernias patient experienced infection.

• Brand Name: C-QUR V-PATCH MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: theresa morin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 7027901
• MDR Text Key: 91904461
• Report Number: 3011175548-2017-00222
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312027
• UDI-Public: 00650862312027
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/11/2020
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 414858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2017
• 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): Required Intervention