• 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 CORP. C-QUR 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 CORP. C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31542
Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)
Patient Problems Abscess (1690); Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
A thorough review of the device history and sterilization records indicates that this lot of hernia mesh passed all quality inspections and performance inspections. Based on the details of the complaint and acceptable lot qualification results atrium medical can find no fault with the product in question.
 
Event Description
Allegedly, patient also experienced recurrence of hernia, chronic non-healing wound, and wound drainage.
 
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.
 
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. Allegedly, following the implant of mesh plaintiff experienced failure of mesh to properly incorporate, chronic pain, foreign body response, infection, scarification, excessive and chronic inflammation, adhesions to internal organs, abscess, seroma formation, panniculitis, inability to remove mesh in its entirety and other complications. 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 NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
40 continental blvd.
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03051
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6785015
MDR Text Key112057602
Report Number3011175548-2017-00081
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2015
Device Model Number31542
Device Catalogue Number31542
Device Lot Number10846776
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2012
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: 08/10/2017 Patient Sequence Number: 1
-
-