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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Fluid Discharge (2686)
Event Type  Injury  
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided and there is no contact information for the complainant. Clinical evaluation. Possible complications that should be considered prior to the use of any surgical mesh include pain, inflammation, recurrence of hernia and seroma to name a few. Hernia recurrence, pain and fluid collection may be caused by incorrect mesh fixation and stress on the mesh due to activity or body type. Complications can occur due to a technical error, inadequate suture fixation and/or inadequate overlap that may lead to mesh contracture and other complications. The compromised patient undergoing a second procedure for explant has additional risks of a repeated surgery.
 
Event Description
Received a report that after the mesh was implanted patient had to have fluid drained from abdomen allegedly due to mesh erosion. The pain, as well as the fluid building up in patients abdomen, continued. After the mesh was explanted the patient continued to be in pain.
 
Manufacturer Narrative
This follow up report is for the inclusion of report mw5058872.
 
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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 Key5393881
MDR Text Key36908733
Report Number1219977-2016-00015
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 other
Type of Report Initial,Followup
Report Date 01/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2016
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: 01/27/2016 Patient Sequence Number: 1
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