MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH

Model Number 31526

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994)

Event Date 03/18/2011

Event Type  Injury  

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 the use of atrium medicals mesh product.Plaintiff alleges the following: a mesh was implanted to repair a hernia.The plaintiff allegedly suffered an adverse reaction and the mesh was removed.At removal, it was noted some area of granulation, inflammation and scarring.Cultures taken at time of removal show no evidence of infection.Since this 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

A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.

Manufacturer Narrative

Investigation: review of manufacturing and sterilization records found no issues during manufacture or sterilization.

Event Description

Allegedly plaintiff also experienced pain, mesh deformation, mesh migration, mesh removal requiring additional surgery, wall behind mesh inflamed and thickened, dense adhesions, adhesions of mesh to appendix requiring appendectomy.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• 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: 4072102
• MDR Text Key: 16775948
• Report Number: 1219977-2014-00273
• 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: Unknown,other,unknown
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 31526
• Device Catalogue Number: 31526
• Device Lot Number: 10659442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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: 57 YR