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

Model Number 31628

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Hernia (2240)

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.

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 chronic pain, recurrence hernia, foreign body response, rejection, infection, failure of incorporation/ingrowth, scarification, improper wound healing, excessive and chronic inflammation, allergic reaction, adhesions to internal organs, erosion, abscess, fistula, granulomatous response, seroma formation, and tissue damage.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 and sterilization records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirements.

Event Description

N/a.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12611668
• MDR Text Key: 275922562
• Report Number: 3011175548-2021-01047
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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: 10/26/2020
• Device Model Number: 31628
• Device Catalogue Number: 31628
• Device Lot Number: 422966
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male