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

Model Number 31534

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Emotional Changes (1831); Foreign Body Sensation in Eye (1869); Hemorrhage/Bleeding (1888); Inflammation (1932); Necrosis (1971); Pain (1994); Scarring (2061); Seroma (2069); Tissue Damage (2104); Hernia (2240); Therapeutic Response, Decreased (2271); Discomfort (2330)

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.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.

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 inadequate incorporation, chronic pain, chronic inflammation and foreign body response, recurrent abscess, recurrent hernias, mental anguish, extreme pain, seromas, loss of comfort, tissue damage, scarring, mental pain and suffering.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 requirements.

Event Description

Plaintiff allegedly also experienced infection, foamy histiocytes, necrosis, sinus tracts, drainage, fibrosis, debridement, granuloma, hemorrhage and non-healing wound.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7924154
• MDR Text Key: 122300918
• Report Number: 3011175548-2018-01098
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

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: 04/30/2013
• Device Model Number: 31534
• Device Catalogue Number: 31534
• Device Lot Number: 10631368
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2010
• 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): Required Intervention
• Patient Age: 52 YR