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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
Model Number 31537
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Seroma (2069)
Event Date 05/22/2012
Event Type  Injury  
Event Description
Allegedly, plaintiff also experienced incarceration, adhesions, hematoma, infection, inflammation, granulation, and foreign body reaction.
 
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
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 plaintiff developed seroma after the mesh was implanted for repair of a symptomatic incisional hernia. 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.
 
Manufacturer Narrative
The available lot history information showed that the lot was sterilized acceptably, and that the device was manufactured and released according to the appropriate manufacturing procedures and relevant specifications. There were no deviations or non-conformances noted during the course of this review.
 
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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 Key5718943
MDR Text Key110109602
Report Number1219977-2016-00126
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 company representative,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 06/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2014
Device Model Number31537
Device Catalogue Number31537
Device Lot Number10734296
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 Received12/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2011
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: 06/10/2016 Patient Sequence Number: 1
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