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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 31535
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
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 c-qur 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: c-qur products are provided sterile. The instructions for use advise to use sterile technique when using the mesh. It was reported that the patient experienced complications following the implant of surgical mesh. Fistulas are a known complication of incisional hernia repairs using prostheses. Risk factors include surgical technique used in fixation, presence of suture abscesses, and patient factors including obesity, diabetes mellitus, elder age and poor nutritional status. Fistulas are a late complication of repairs with mesh particularly if the mesh is in direct contact with the intestine and may be caused by chronic infection. Atrium's mesh with omega three fatty acids (o3fa) will typically absorb over 19-24 months under normal healing conditions. 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. Any surgery that causes a break in the skin can lead to a postoperative infection. 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. Other risks for ssis include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes. The instructions for use state, "complications may occur with the use of any surgical mesh including, but not limited to fistula formation and infection. Adequate mesh fixation is required to minimize post operative complications and recurrence. " related file 1219977-2016-00224.
 
Event Description
Approximately four weeks after mesh was implanted it was explanted due to infection and fistula.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
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 Key6149107
MDR Text Key61559101
Report Number1219977-2016-00243
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 11/20/2016
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 Date08/31/2017
Device Model Number31535
Device Catalogue Number31535
Device Lot Number214181
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 Received11/20/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/29/2014
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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