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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
Device Problem Material Integrity Problem (2978)
Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Patient had laparoscopic hernia repair approximately one year ago. Three months ago there was a query of immunodeficiency and lupus so the patient was put on steroids. Patient developed wound complications, cellulitis, abdominal pain and discharge. Surgeon took patient back into the operating room and mesh was completely intact with no incorporation into surrounding tissue. Described mesh as being like it was tofu - green in color and lumpy. Mesh was removed. Pathology on mesh and tofu-like substance came back as sterile.
 
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Brand NameC-QUR MESH
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 Key5172009
MDR Text Key29198954
Report Number1219977-2015-00311
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 10/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2015
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 Received10/08/2015
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/24/2015 Patient Sequence Number: 1
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