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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 Insufficient Information (3190)
Patient Problems Injury (2348); Post Operative Wound Infection (2446)
Event Type  Injury  
Event Description
Allegedly atrium mesh product was not used for this hernia repair. A bard mesh was used on this patient.
 
Manufacturer Narrative
A thorough investigation was not able to be performed as no product code, lot number, or sample was provided. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit and described herein are or were defective, or that it had any casual relationship to any injuries allegedly sustained by the plaintiff.
 
Event Description
This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product. Allegedly, after the mesh was implanted the plaintiff suffered injury. Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege. However, atrium will supplement this report as appropriate if additional information comes to its attention.
 
Event Description
Allegedly plaintiff had surgery in an attempt to repair hernias using mesh. Subsequent to the surgery, plaintiff alleges he began to feel pain, swelling, and other symptoms associated with infection.
 
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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 03051
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key5452449
MDR Text Key111218720
Report Number1219977-2016-00029
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 02/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2016
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/03/2017
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: 02/22/2016 Patient Sequence Number: 1
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