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

Model Number 31612

Device Problems Contamination (1120); Material Deformation (2976)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Failure of Implant (1924); Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.

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, following the implant of c-qur tacshield mesh, the plaintiff experienced pain, inflammation, mesh deformation, mesh removal and recurrent hernia requiring additional surgery, infected mesh, abdominal abscess, purulent fluid surrounding the mesh, extensive adhesions, inflamed omentum causing inflammatory rind.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 the plaintiff also experienced blood loss, fibrosis, necrosis and granulomatous tissue.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7046381
• MDR Text Key: 92586902
• Report Number: 3011175548-2017-00300
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 31612
• Device Catalogue Number: 31612
• Device Lot Number: 10792572
• Other Device ID Number: 00650862316124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/14/2018
• Date Device Manufactured: 09/28/2011
• 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