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

Model Number 31201

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Report received from of infection with mesh that had to be explanted.Cultures were done on explants and they showed skin flora along with other bacteria.

Manufacturer Narrative

(b)(4).Upon completion of the investigation into this event a follow up report will be submitted.Related reports: 1219977-2015-00195, 1219977-2015-00196, and 1219977-2015-00197.

Manufacturer Narrative

Investigation: a review of the lot history and sterilization records was conducted.No deviations were noted or found in any of the documentation and all release criteria was met, including testing for suture retention (coarse and wale), fourier-transform infrared spectrophotometry (ftir), and ball burst conducted on the mesh at incoming and in-process ftir testing of the cured coated panel.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 through microorganisms that are already on or in your body and then spread into the wound.Infections may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.The instructions for use precaution against handling of the mesh without clean sterile gloves and instruments.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.

Event Description

Patient was being treated for upper and lower hernia repair.

• 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 ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4942104
• MDR Text Key: 6196568
• Report Number: 1219977-2015-00198
• 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: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 31201
• Device Catalogue Number: 31201
• Device Lot Number: 210202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• 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