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

Model Number	31537
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Seroma (2069)
Date of Event	05/22/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
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 medicals mesh product.Allegedly plaintiff developed seroma after the mesh was implanted for repair of a symptomatic incisional hernia.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.
Additional Manufacturer Narrative
The available lot history information showed that the lot was sterilized acceptably, and that the device was manufactured and released according to the appropriate manufacturing procedures and relevant specifications.There were no deviations or non-conformances noted during the course of this review.
Event or Problem Description
Allegedly, plaintiff also experienced incarceration, adhesions, hematoma, infection, inflammation, granulation, and foreign body reaction.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• MDR Report Key: 5718943
• Report Number: 1219977-2016-00126
• Device Sequence Number: 180911
• Product Code: FTL
• UDI-Device Identifier: 00650862315370
• UDI-Public: 00650862315370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2016

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: 04/30/2014
• Device Model Number: 31537
• Device Catalogue Number: 31537
• Device Lot Number: 10734296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided; 12/04/2017
• Initial Report FDA Received Date: 06/10/2016
• Supplement Report FDA Received Date: 06/17/2016; 12/20/2017
• 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
• Patient Age: 49 YR