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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH; MESH, SURGICAL, POLYMERIC
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ATRIUM MEDICAL CORP. C-QUR MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Detachment Of Device Component (1104); Microbial Contamination of Device (2303)
Patient Problems Fistula (1862); Unspecified Infection (1930); Seroma (2069)
Event Type  Injury  
Event Description
After mesh implantation, the pt presented abdominal pain, inflammation of abdominal wall, seroma, and a fistula.The mesh was explanted.During explant procedure, the mesh was found only partially attached.Explanted mesh was determined to be infected - escherichia coli.The pt was given antibiotics.
 
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 MESH
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 Key4107020
MDR Text Key20064251
Report Number1219977-2014-00299
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
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
Date FDA Received09/11/2014
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
Date Manufacturer Received08/13/2014
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;
Patient Age67 YR
Patient Weight81
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