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

Model Number 1000204-01

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

Patient Problems Pain (1994); Hernia (2240)

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 an atrium medical mesh product.Plaintiff allegedly experienced prostatic hypertrophy with lower urinary tract symptoms, nerve entrapment and revision surgery as a result of the implantation of the mesh implant.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

Investigation: 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 requirement.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.

• Brand Name: MESH PROLITE PRESHAPES
• 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
• MDR Report Key: 13020387
• MDR Text Key: 282379041
• Report Number: 3011175548-2021-01315
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862300239
• UDI-Public: 00650862300239
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: 1000204-01
• Device Catalogue Number: 1000204-01
• Device Lot Number: 416167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male