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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Received a report of patient having an allergic reaction. The mesh was explanted.
 
Manufacturer Narrative
Additional information received stated that the doctor did not have patients with allergic reaction to the fish oil. The doctor had instead one patient that had seroma. We are unable to fully investigate this event as the user faciltiy has not provided product code or lot number used in this event. Clinical evaluation: a seroma is a collection of fluid under the skin. Usually it occurs at the site of a surgical incision and may form about one to two weeks after surgery. It may look like a swollen lump and feel tender or sore and there may be drainage. A small seroma is not dangerous. However, a large seroma that is causing pain may need to be drained. Occasionally a procedure may need to be performed to remove the seroma and/or explant the graft. C-qur mesh has an o3fa coating that is derived from highly purified pharmaceutical grade fish oil consisting of a unique blend of triglycerides and omega 3 fatty acids. Highly refined oils may be derived from a priority food allergen source; however, because of the degree to which they have been refined, they contain no protein. Because omega three fatty acids are highly refined they are not allergenic. The instructions for use state that complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs. Seroma post implant of any mesh product may be caused by improper fixation methods. Careful attention to proper fixation techniques and sizing of the product should be taken to help prevent excessive tension or disruption between the graft material and tissue.
 
Event Description
Received updated information from surgeon. Obese middle aged female who developed a sizeable seroma after placing mesh for umbilical hernia. It was cultured, sterile, wound failed to hear with aggressive local care and mesh was explanted with primary fascial closure. Patient did well.
 
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Brand NameC-QUR V-PATCH
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 Key5819218
MDR Text Key50333684
Report Number1219977-2016-00167
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090909
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 07/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2016
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 Received08/15/2016
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: 07/25/2016 Patient Sequence Number: 1
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