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

Model Number	31533
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A thorough review of the device history records indicates that this lot of hernia mesh passed all quality inspections and performance inspections.A review of the sterility records indicates that this lot of mesh product was sterilized properly without any cycle deviations during the process of sterilization.Based on the details of the complaint and acceptable lot qualification results atrium medical can find no fault with the product in question.
Event or Problem Description
This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical's mesh product.Allegedly, plaintiff was implanted with c-qur mesh.Plaintiff allegedly experienced recurrent hernia, excess adhesions of the omentum into the hernia, infection, adverse tissue reaction, inflammation, additional surgery, pain and suffering, emotional trauma.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• MDR Report Key: 7028483
• Report Number: 3011175548-2017-00254
• Device Sequence Number: 19067540
• Product Code: FTL
• UDI-Device Identifier: 00650862315332
• UDI-Public: 00650862315332
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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
• Operator of Device: Physician
• Device Expiration Date: 10/31/2013
• Device Model Number: 31533
• Device Catalogue Number: 31533
• Device Lot Number: 10706807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention