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

Model Number 31202

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/12/2015

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.Related reports: 1219977-2015-00195, 1219977-2015-00196, 1219977-2015-00197, 1219977-2015-00198.

Event Description

Received report that patient acquired an infection.Cultures were taken and antibiotics given.Mesh was explanted.

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.Medical record review: a review of limited medical records revealed that the c-qur v-patch was explanted due to a suspicion of a chronically infected mesh.Cultures revealed scant growth of s.Lugdunensis which requires aggressive treatment in order to prevent more significant complications and s.Epidermidis which is part of normal human flora.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.

• 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: 5001769
• MDR Text Key: 22942916
• Report Number: 1219977-2015-00233
• 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
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• 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: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 207133
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2014
• 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: 71 YR