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 08/12/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received a report of a possible infection less than 30 days after mesh was implanted.

Manufacturer Narrative

Investigation: a review of the manufacturing lot history and sterilization records for the reported lot was conducted.All in-process specifications and release criteria were met, including testing for suture retention (course and wale), residual lubricant testing by gc, and ball burst conducted on the mesh at incoming.Fourier-transform infrared spectrophotometer testing of the cured fish oil coated panels, stitch strength testing of the sewn pallet, and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met.Based on the lot records, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture.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.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.The ifu 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: 5056737
• MDR Text Key: 25021468
• Report Number: 1219977-2015-00264
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 217490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2014
• 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: 41 YR
• Patient Weight: 137