• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL PROLITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000303-00
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Perforation (2001); Hernia (2240); Impaired Healing (2378); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

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

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 stomach pain, recurrent hernia, perforation of tissue and /or organs, adherence to tissue/organs, nonhealing wound, infection, nerve damage, additional surgeries, digestion difficulty, difficulty walking, and sexual performance issues. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLITE MESH
Type of DeviceMESH, 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 Key7462566
MDR Text Key106575102
Report Number3011175548-2018-00402
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 04/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2016
Device MODEL Number1000303-00
Device Catalogue Number1000303-00
Device LOT Number10731426
OTHER Device ID Number00650862300048
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/07/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/25/2018 Patient Sequence Number: 1
-
-