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

Model Number 31633

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Erosion (1750); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Tissue Damage (2104); Hernia (2240); Therapeutic Response, Decreased (2271); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.

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 of 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, 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

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 requirement.

Event Description

Plaintiff also allegedly experienced recurrence, adhesions, enterotomy, ileus, hematoma and seroma.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7971427
• MDR Text Key: 123937808
• Report Number: 3011175548-2018-01152
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 31633
• Device Catalogue Number: 31633
• Device Lot Number: 10796076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2011
• 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