• 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 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 CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Deformation (2976)
Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event. Related report: submitted 1219977-2015-00311 on (b)(6) 2015 and could not obtain fda acknowledgements. Only the first acknowledgement was received. Sent message to esg help desk and received confirmation of help requested but no follow up. It has been two weeks. Filing a new report to assure fda timeframe for reporting is met.

 
Event Description

Patient had laparoscopic hernia repair approximately one year ago. Three months ago there was a query of immunodeficiency and lupus so the patient was put on steroids. Patient developed wound complications, cellulitis, abdominal pain and discharge. Surgeon took patient back into the operating room and mesh was completely intact with no incorporation into surrounding tissue. Described mesh as being like it was tofu/green in color and lumpy. Mesh was removed. Pathology on mesh and tofu-like substance came back as sterile.

 
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number or sample was provided. Atrium's mesh with omega three fatty acids (o3fa) will typically absorb over 19-24 months under normal healing conditions. It may take longer on an immunocompromised patient, who is susceptible to bacterial, fungal, and viral infections that healthy immune systems usually conquer. The mesh may be 'free floating' on the abdominal wall due to an error in clinical technique, inadequate suture fixation and/or inadequate placement which will cause separation of the mesh from the abdominal wall. Adequate fixation and proper placement is necessary for mesh incorporation. The o3fa gel coating on the c-qur mesh breaks down via hydrolysis by body fluids into naturally occurring fatty acids and glycerides, which are readily absorbed by normal lipid metabolism. Furthermore, the anti-inflammatory properties of omega-3 fatty acids may contribute to a low-grade inflammatory response of the c-qur o3fa coated mesh as compared with bare polymer mesh. The instructions for use state in adverse reactions, "complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection, seroma, hematoma, fistula formation, mechanical disruption of the tissue and/or mesh material and possible adhesions when placed in direct contact with the viscera (intestines) and organs.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5201119
MDR Text Key30386063
Report Number1219977-2015-00322
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/04/2015 Patient Sequence Number: 1
-
-