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

Model Number 1000204-00 - MESH 2X4 HERNIA REPAIR

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

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.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.

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.Plaintiff allegedly experienced severe injury, adhesions, hematoma, infection, recurrent hernia, pain, additional medical care treatment or surgery, severe scar tissue, drainage and mesh ball contracted.Note: mesh was soaked in bacitracin saline ¿ off label.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

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.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.

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.Plaintiff allegedly experienced severe injury, adhesions, hematoma, infection, recurrent hernia, pain, additional medical care treatment or surgery, severe scar tissue, drainage and mesh ball contracted.Note: mesh was soaked in bacitracin saline ¿ off label.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.

• Brand Name: C-QUR PROLITE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 13477008
• MDR Text Key: 285213787
• Report Number: 3011175548-2022-00047
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862300024
• UDI-Public: 00650862300024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2022

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: 03/31/2018
• Device Model Number: 1000204-00 - MESH 2X4 HERNIA REPAIR
• Device Catalogue Number: 1000204-00
• Device Lot Number: 10881922
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female