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

Model Number 31200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.Related mdrs: 3011175548-2016-00002, 3011175548-2016-00003.

Event Description

Received a report of infection.Mesh was removed.Culture grew scedosporium apiospermum.

Manufacturer Narrative

A review of lot history and sterilization records was performed.The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre & post sterile pouches.All raw materials met all incoming testing and inspections.Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release.Clinical evaluation: 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 surgical site infection (ssi) may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.Most ssis can be treated successfully with antibiotic medications.Sometimes additional surgery or procedures may be required.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 MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP; 40 continental blvd.; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORP; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5775816
• MDR Text Key: 48975688
• Report Number: 3011175548-2016-00004
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312003
• UDI-Public: 00650862312003
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 31200
• Device Catalogue Number: 31200
• Device Lot Number: 401129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• 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: 70 YR