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

Model Number	31626
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the pre-suit claim and described herein are or were defective, or that it had any causal relationship to any injuries allegedly suffered by the claimant.
Event or Problem Description
This event is deemed reportable based on the allegations in a pre-suit claim which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.Claimant attributes unspecified complications to the mesh.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
A review of all manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile packaging.Ball burst and suture retention testing was also conducted on the mesh at incoming and fourier transform infrared spectroscopy was performed on the cured coated mesh panels.
Event or Problem Description
Allegedly, the patient continued to develop new areas of herniation and failed repairs due to muscle wall weakness.
Event or Problem Description
Allegedly, plaintiff also experienced abdominal pain, adhesions, umbilical recurrent hernia, fat necrosis and small bowel obstruction.

• Brand Name: C-QUR TACSHIELD
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• MDR Report Key: 5821653
• Report Number: 1219977-2016-00153
• Device Sequence Number: 1320286
• Product Code: FTL
• UDI-Device Identifier: 00650862316261
• UDI-Public: 00650862316261
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/14/2016

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: 31626
• Device Catalogue Number: 31626
• Device Lot Number: 10739855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 11/22/2017
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 07/29/2016; 08/31/2016; 12/13/2017
• 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: 60 YR