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

Model Number 30717

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240)

Event Type  Injury  

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.Device evaluated by mfr: not returned.

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 extreme pain, mesh migration, revision, adhesions, additional surgeries, hospitalization, infection and inflammation.Prolite mesh was soaked in antibiotics off-label.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.

• Brand Name: MESH PROLITE ULTRA SHEETS
• 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: 40 continental blvd; merrimack, NH
• MDR Report Key: 10941647
• MDR Text Key: 219487561
• Report Number: 3011175548-2020-01404
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862307177
• UDI-Public: 00650862307177
• Combination Product (y/n): N
• PMA/PMN Number: K002093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/03/2020

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: 02/28/2018
• Device Model Number: 30717
• Device Catalogue Number: 30717
• Device Lot Number: 10876964
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2013
• 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: 51 YR