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

Model Number 31202

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932)

Event Type  Injury  

Event Description

This event is deemed reportable based on the allegations in a lawsuit, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.Plaintiff was allegedly implanted with a mesh and suffered an adverse event (chronic inflammation with foreign body giant cell reaction).Allegedly an abcess was removed, but the fluid revealed no bacteria growth and cultures taken at time of removal indicated no infection.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

(b)(4).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.

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Manufacturer Narrative

The lot history records and sterilization records were reviewed.The lot history information showed that the lot was sterilized acceptably, and that the device was manufactured and released according to the appropriate manufacturing procedures and relevant specifications.

• Brand Name: C-QUR V-PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 4915596
• MDR Text Key: 20150964
• Report Number: 1219977-2015-00191
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 10730577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2011
• 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