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

Model Number 31332

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

Patient Problems Abdominal Pain (1685); Pain (1994); Rash (2033); Scar Tissue (2060); Hernia (2240)

Event Date 04/11/2012

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 atrium medicals mesh product.Plaintiff alleges the following: two months after surgery she broke out a rash all over her body and plaintiff alleges that fish oil is causing it.Plaintiff had at least three hernias at the time.During post-op checkup, plaintiff reported pain.Since this a potential legal matter, the case has been turned over to legal counsel and further info 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 add'l info comes to its attention.

Manufacturer Narrative

A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.Review of the medical records rec'd revealed that this pt has had chronic pain before the surgery.Post surgery there was no signs of infection or inflammation.The pt rash started two months after surgery.The pt had prescription for fish oil pills 1,000 mg daily as well as allergy shots prescribed for every two weeks.

Event Description

Plaintiff also allegedly experienced hives, blisters, terrible itching, nausea, sickness, biopsy, allergic to mesh, swelling, drainage, ischemia, necrosis, granuloma, benign fibrosis, recurrence, reaction to mesh, fascial plication and umbilicoplasty closure.

Event Description

Plaintiff also allegedly experienced pain, systemic chronic reaction, excessive skin and scar tissue removed.

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 requirements.

• Brand Name: C-QUR LITE MESH
• 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 03051 ; 6038801433
• MDR Report Key: 3733261
• MDR Text Key: 4308968
• Report Number: 1219977-2014-00116
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862313321
• UDI-Public: 00650862313321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

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: 01/31/2013
• Device Model Number: 31332
• Device Catalogue Number: 31332
• Device Lot Number: 10588107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2013
• Initial Date FDA Received: 03/28/2014
• Supplement Dates Manufacturer Received: 12/13/2021; 03/15/2022
• Supplement Dates FDA Received: 01/06/2022; 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2010
• 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): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 50 KG