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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 31105
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 10/26/2016
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted at the completion of the investigation into this event.
 
Event Description
Received report that a surgeon placed mesh into abdomen and after tacking saw excessive flaking of the omega 3 fatty acids. Surgeon placed a second mesh to cover the initial mesh.
 
Manufacturer Narrative
Additional information: pt identifier, age/date of birth, sex, weight and concomitant medical products. 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 (course and wale) 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 mosaic panels and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met. Pictures of the sample were provided; however, no conclusions could be drawn without having the physical sample to evaluate. Clinical evaluation: c-qur" mosaic mesh has a coating derived from biological oil composed of fatty acids, lipids and glycerides (bao bio-absorbable oil coating). It has a coating that is absorbable by the body and if in the event it does flake or come off during a procedure it would cause no harm to the patient, the mesh would then become the equivalent of bare mesh. A physician may determine a product is not suitable for an intended procedure at any time and for any reason he deems significant enough to compromise patient outcomes. In the event the physician has a change of plan during a procedure it would result in a delay in treatment. The instructions for use state under adverse reaction, that complications may occur with the use of any surgical mesh include, but are not limited to, mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs.
 
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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
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key6064376
MDR Text Key58669405
Report Number3011175548-2016-00008
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,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/27/2018
Device Model Number31105
Device Catalogue Number31105
Device Lot Number401313
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 Received11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2015
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: 10/28/2016 Patient Sequence Number: 1
Treatment
ABSORBABLE TACKS
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