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

Model Number 31628

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.Related files: 3011175548-2017-00216 and 3011175548-2017-00217.

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 tacshield mesh.Plaintiff allegedly experienced mesh failure, seroma, infection, need for further surgery, pain and suffering, mental anguish and continuing disability.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 and sterilization 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 patient also experienced recurrence and adhesions.

• Brand Name: C-QUR TACSHIELD MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• 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: 6982196
• MDR Text Key: 90392080
• Report Number: 3011175548-2017-00215
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100076
• 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: 10/26/2017

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
• Device Operator: Physician
• Device Expiration Date: 10/31/2013
• Device Model Number: 31628
• Device Catalogue Number: 31628
• Device Lot Number: 10699416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2010
• 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