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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31540
Device Problems Contamination (1120); Device Contamination With Biological Material (2908); Device Operates Differently Than Expected (2913)
Patient Problem Post Operative Wound Infection (2446)
Event Date 10/14/2016
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the conclusion of the investigation into this event.
 
Event Description
Patient with ventral hernia in which a mesh did not integrate. The patient developed wound infection eight weeks after surgery and the mesh was removed. Cultures showed enterobacteriaceae staphylococcus. Antibiotics were given.
 
Manufacturer Narrative
A review of the manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including testing for suture retention and ball burst conducted on the mesh at incoming. Fournier transform infrared spectroscopy testing and coating density of the cured omega-3 fatty acids coated panels and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met. Clinical evaluation: a mesh may not integrate due to, but not limited to infection, incorrectly sized mesh or inadequate fixation. This event could require the patient to undergo a second surgery to correct the defect in order to prevent further complication. C-qur mesh products are provided sterile. The handling of all mesh should be with sterile gloves and/or instruments. Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound. Enterobacteriaceae is a bacterial infection that makes up as many as half of the hospital acquired infections in the united states. Other risks for surgical site infections (ssi) include smoking, elderly and/or overweight patients, those with weakened immune systems and diabetes. Most ssis can be treated successfully with antibiotic medications. Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue. The instructions for use state adequate mesh fixation is required to minimize post-operative complications and recurrence and complications may occur with the use of any surgical mesh include, but are not limited to pain, seroma, mechanical disruption of the tissue and /or mesh and adhesions when placed in direct contact with the viscera and other organs.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
40 continental blvd.
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6148626
MDR Text Key61544208
Report Number3011175548-2016-00013
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K050311
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 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Model Number31540
Device Catalogue Number31540
Device Lot NumberP15332
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 Received12/09/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/22/2015
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: 12/06/2016 Patient Sequence Number: 1
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