MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH PROLITE SHEETS; MESH, SURGICAL, POLYMERIC

Model Number 1001014-00 - MESH 10X14 CHEST/HERNIA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Granuloma (1876); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product.Plaintiff allegedly experienced hernia recurrence, adhesions, scar revision fibro connective tissue with chronic inflammation, drainage and foreign body giant cell granulomas.Since this is a potential 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

We are unable to fully investigate this event as no lot number, or sample was provided.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the pre-suit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the claimant.

• Brand Name: MESH PROLITE SHEETS
• 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: 16280255
• MDR Text Key: 308588556
• Report Number: 3011175548-2023-00035
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862300093
• UDI-Public: 00650862300093
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1001014-00 - MESH 10X14 CHEST/HERNIA
• Device Catalogue Number: 1001014-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American