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

Model Number 31105

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted on completion of the investigation into this event.

Event Description

Received a report that a patient had mesh implanted for lap ventral hernia repair.Patient went back to hospital within one or two days complaining of abdominal pain.Patient had a scan and doctor stated it was probably due to blood in the abdomen.

Manufacturer Narrative

A review of lot history and sterilization records was performed.The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre & post sterile pouches.All raw materials met all incoming testing and inspections.Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release.Clinical evaluation: laparoscopic hernia repair uses an instrument called a laparoscope.Between two and four small incisions are made through the abdominal wall through which are passed the laparoscope and surgical instruments into the abdomen.The hernia is then viewed from inside the abdomen.The abdominal cavity is inflated with carbon dioxide gas to give the surgeon space to work inside the patient and the actual operating is done remotely with long instruments.The hernia defect or hole is covered with mesh from within the abdomen and staples commonly fired through it into the muscle tissue in order to fix it as a patch.Pain is a recognized complication of many common procedures including laparoscopic hernia repair.Surgical technique can influence the development of post-surgical pain and techniques to minimize nerve injury should be used whenever possible.The instructions for use state, "complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection and pain." the fixation technique, method, and products used, including sutures, tacks, etc.) is left to the discretion of the surgeon to optimize clinical outcomes.

• Brand Name: C-QUR MOSAIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5727326
• MDR Text Key: 47487770
• Report Number: 1219977-2016-00133
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: 31105
• Device Catalogue Number: 31105
• Device Lot Number: 216294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2014
• 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