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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR V PATCH; MESH, SURGICAL, POLYMERIC
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ATRIUM MEDICAL CORP. C-QUR V PATCH; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Adhesion(s) (1695); Pain (1994); Seroma (2069)
Event Type  Injury  
Event Description
Pt presented yellow discharge through the surrounding wound, abdominal pain, abdominal distension, and impossibility to release gas.X-ray was performed showing bowel distension.During surgery, it was found that a loop of bowel was attached to the mesh.The mesh was retrieved with a 5 cm segment of small intestine.
 
Manufacturer Narrative
We are in the process of performing the investigation and will submit the f/u report once the eval is completed.
 
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Brand Name
C-QUR V PATCH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key4107029
MDR Text Key4697414
Report Number1219977-2014-00305
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/13/2014
Initial Date FDA Received09/11/2014
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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