• 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 Torn Material (3024)
Patient Problem No Information (3190)
Event Date 11/10/2015
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Received report that during a laproscopic hernia surgery the mesh ripped when the doctor was trying to fixate the mesh using a protack fixation device.
 
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided. The instructions for use states the following "the fixation technique, method, and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes. " it further states "careful attention to suture, staple, and/or tack placement and spacing will help prevent excessive tension or disruption of the mesh material and/or underlying tissue. It is recommended that sutures, staples, and/or tacks be placed a minimum of 6. 5 mm from the edge of the mesh and spaced 2 cm apart from each other for best results. " in addition, each incoming lot of mesh is tested for strength on an instron with both suture retention and ball burst tests. Clinical evaluation: the mesh may tear as a result of a technical error, improper suture fixation and incorrect sizing which will cause stress and tension of the mesh. Important aspects of user experience include the necessity of having operative planning with full identification of the extent of the hernia, adept skills in the application of sutures/tacks, and reconstruction skills assuring closure of the wound in layers and coverage of the implanted mesh with minimal space for serous collections and no direct pathway to the mesh from the skin. The instructions for use instructs that mesh products should be shaped, sized and anchored taking into consideration the patient's posture, weight and anatomical location. In order to minimize anchor disruption the mesh should be sized and positioned so that it extends adequately beyond the margins of the defect.
 
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 Key5220830
MDR Text Key31047694
Report Number1219977-2015-00328
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2015
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 Received12/15/2015
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: 11/12/2015 Patient Sequence Number: 1
-
-