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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 Patient-Device Incompatibility (2682)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
A thorough investigation was not able to be performed as no product code, lot number, or sample was provided. A review of complaints was performed and there have not been any similar reports related to a device malfunction.
 
Event Description
This event is deemed reportable based on the allegations in a lawsuit, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product. Plaintiff was allegedly implanted with a mesh for hernia repair, had multiple infections, and the mesh was explanted. 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.
 
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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 Key5177961
MDR Text Key29250900
Report Number1219977-2015-00310
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
Report Date 10/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2015
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2015
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: 10/26/2015 Patient Sequence Number: 1
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