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

Model Number 31235

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.

Event 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 edge mesh.Plaintiff allegedly experienced recurring hernia resulting in hospitalization and corrective surgery, hernia graft which had rolled upon itself into the upper portion of the abdomen causing infection and mesh adhesion, multiple abdominal surgeries and multiple incisional hernia repairs.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.

Manufacturer Narrative

Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirement.

Event Description

Allegedly plaintiff also experienced blood loss, unincorporation and diastasis recti.

• Brand Name: C-QUR EDGE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: theresa morin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 7006041
• MDR Text Key: 91221661
• Report Number: 3011175548-2017-00262
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2011
• Device Model Number: 31235
• Device Catalogue Number: 31235
• Device Lot Number: 10420135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2008
• 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