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

Model Number 31202

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

Patient Problem Unspecified Infection (1930)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had a recurrent ventral hernia, which was repaired laparoscopically using mesh.Surgeon then performed wound debridement on (b)(6) 2015, as patient had pus coming from sinus next to umbilicus.Mesh was then removed and further debridement of wound occurred, as well as repair with bio-a (gore mesh).Cultured mesh, tissue and fluid and awaiting results.

Manufacturer Narrative

The lot history of was reviewed.Incoming inspection records show the bare mesh used to manufacture this lot passed all suture and ball burst strength requirements.The fish oil used to manufacture this lot passed incoming inspection, including fourier-transform infrared spectrophotometry (ftir) testing.The qc in-process testing completed for each sub-assembly met all release criteria including visual inspection, ftir, pouch peel and stitch strength analysis.Records show that the lot was sterilized acceptably.Based on the available lot information, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture.The engineering evaluation did not find any defects on the mesh sample returned.The sample appeared intact and did exhibit the tissue ingrowth that was noted in the report from the hospital.Clinical evaluation: any surgery that causes a break in the skin can lead to a postoperative infection.Infections may occur 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 will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.Other risks for infection include elderly and/or overweight patients, smokers, and patients with weakened immune systems.Most surgical site infections can be treated successfully with antibiotic medications.Sometimes additional surgery or procedures may be required.It states in adverse reactions, "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.

• Brand Name: C-QUR V-PATCH
• 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: 5235633
• MDR Text Key: 31594404
• Report Number: 1219977-2015-00329
• Device Sequence Number: 1
• Product Code: FTL
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 210655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABSORBABLE TACKS
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 130