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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
Model Number 31535
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
A thorough review of the device history records indicates that this lot of hernia mesh passed all quality inspections and performance inspections. Based on the details of the complaint and acceptable lot qualification results atrium medical can find no fault with the product in question.
 
Event Description
Plaintiff also allegedly experienced incarceration, blood loss and unincorporated mesh.
 
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.
 
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 medical's mesh product. Allegedly, plaintiff was implanted with c-qur mesh. Plaintiff allegedly experienced hernia recurrence, migration, adhesions, severe pain, inability to completely remove the mesh. 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 CORP.
40 continental blvd.
merrimack NH 03054
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 Key6961874
MDR Text Key162717541
Report Number3011175548-2017-00181
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
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2017
Device Model Number31535
Device Catalogue Number31535
Device Lot Number209403
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 Received12/18/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/24/2014
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: 10/19/2017 Patient Sequence Number: 1
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