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

Model Number 31200

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body Reaction (1868)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.Related file: 1219977-2015-00200.

Event Description

Mesh was implanted in patient 10 weeks ago - 3 weeks post op they developed a redness on the skin.Wound had healed well otherwise.Patient was treated with antifungal, clindamycin, fluclox - stopped antibiotics 24 hour pre op and redness decreased.Performed biopsy of skin and microbiology has all come back negative for infection.

Manufacturer Narrative

Investigation: the lot history was reviewed.Incoming inspection records show the bare mesh used to manufacture this lot passed all suture and ball burst strength test requirements.The qc in-process testing completed for each sub-assembly met all acceptance criteria including visual inspection, fourier-transform infrared spectrophotometry, weld strength, and pouch peel strength.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.There were no deviations or non-conformances noted during the course of this review.Clinical evaluation: inflammation is the biological response to something harmful or irritating that affects a part of our body.The signs and symptoms of inflammation, specifically acute inflammation, show that the body is trying to heal itself.Inflammation does not mean infection, even when an infection causes inflammation.Infection is caused by a bacterium, virus or fungus, while inflammation is the body's response to it.Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue.In the event of improper fixation and placement adverse reactions may occur such as inflammation and pain and may require explant of the mesh.The instructions for use state, "an adverse reaction may occur with the use of any surgical mesh when placed in direct contact with the viscera.".

• 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: 5032639
• MDR Text Key: 24142847
• Report Number: 1219977-2015-00257
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2015
• Device Model Number: 31200
• Device Catalogue Number: 31200
• Device Lot Number: 210644
• 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
• 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: 74 YR