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

Model Number 31201

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted following the investigation into this event.

Event Description

Received report that patient developed infection following hernia surgery.

Manufacturer Narrative

A review of the manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile atrium-applied packaging.Clinical evaluation: 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 in your body.Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.Other risks for infection include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes.Most surgical site infections can be treated successfully with antibiotic medications.Sometimes additional surgery or procedures may be required to treat the ssi or explant the mesh.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: 5364722
• MDR Text Key: 35917197
• Report Number: 1219977-2016-00005
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080688
• 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: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2017
• Device Model Number: 31201
• Device Catalogue Number: 31201
• Device Lot Number: 216214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2014
• 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
• Patient Age: 53 YR
• Patient Weight: 117