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

Model Number 1000606-00

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

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.Allegedly, four months after mesh being implanted to repair a ventral hernia the patient developed bronchitis and noticed a lot of pain the area of the hernia repair when she coughed.Allegedly, surgeon could not remove all of the mesh due to adhesions.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

A review of the manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met.

• Brand Name: PROLITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORP.; 5 wentworth drive; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: theresa morin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 6412562
• MDR Text Key: 70174771
• Report Number: 1219977-2017-00038
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00065086230007
• UDI-Public: 0065086230007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

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: Physician
• Device Expiration Date: 06/30/2010
• Device Model Number: 1000606-00
• Device Catalogue Number: 1000606-00
• Device Lot Number: 10019056
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2005
• 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