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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MOSAIC MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORP. C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31106
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2017
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted on the completion of the investigation into this event.
 
Event Description
When surgeon tried to pass a suture through the middle of the product, the product had a hole torn in it.
 
Manufacturer Narrative
A review of all lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including pre-and-post-sterile seal strength testing on the packaging and fourier-transform infrared spectroscopy (ftir) and coating density testing on the cured coated panel. Ball burst, suture retention (course and wale directions), and ftir testing was conducted on the polypropylene mesh material at incoming and all acceptance criteria was also met. Clinical evaluation: the c-qur mosaic mesh is intended for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical interventional procedures requiring reinforcement with a supportive material. Complications that may occur with the use of any surgical mesh include, but are not limited to inflammation, pain and mechanical disruption of tissue. The instructions for use (ifu) states adequate mesh fixation is required to minimize post-operative complications. A product may tear during suturing if it is incorrectly sized for the planned intervention, if excessive tension exists between the mesh material and the tissue and if the suture/staples/tackers are not placed adequately. The mesh product should be shaped, sized and anchored taking into consideration the patient's posture, weight and anatomical location. In order to minimize tension at the suture line, the mesh should be sized and positioned so that it extends adequately beyond the margins of the defect. The instructions for use (ifu) advise that careful attention to suture/staple/tacker placement and spacing will help to prevent excessive tension or disruption of the mesh material or underlying tissue. The ifu states adequate mesh fixation is required to minimize post-operative complications. The fixation technique, method, and products used are left to the discretion of the surgeon to optimize clinical outcomes.
 
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Brand NameC-QUR MOSAIC
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
40 continental blvd.
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
10 bowman drive
hudson, NH 03051
6038645237
MDR Report Key6383325
MDR Text Key69509222
Report Number3011175548-2017-00008
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 03/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2019
Device Model Number31106
Device Catalogue Number31106
Device Lot Number407066
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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