• 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 CORPORATION C-QUR EDGE 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 CORPORATION C-QUR EDGE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31233
Device Problem Insufficient Information (3190)
Patient Problems Ischemia (1942); Pain (1994); Renal Failure (2041)
Event Date 02/28/2008
Event Type  Injury  
Event Description
Allegedly patient also experienced ischemia colitis.
 
Manufacturer Narrative
A follow up report will be submitted upon 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. Related mdr's: 1219977-2016-00172.
 
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, claimant experienced increased gastrointestinal problems and renal failure, in conjunction with constant abdominal pain and tenderness. 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 all manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile packaging. Ball burst and suture retention testing was also conducted on the mesh at incoming and fourier transform infrared spectroscopy was performed on the cured coated mesh panels.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR EDGE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
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 Key5853957
MDR Text Key111356585
Report Number1219977-2016-00171
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 07/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2008
Device Model Number31233
Device Catalogue Number31233
Device Lot Number10177010
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 Received10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2007
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: 08/08/2016 Patient Sequence Number: 1
-
-