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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR V-PATCH MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORP. C-QUR V-PATCH MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problem Unintended Movement (3026)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240)
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 inflammation and adhesions.
 
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, following the implant of c-qur v-patch mesh plaintiff experienced severe contraction of mesh causing recurrence, chronic pain, and additional surgery. 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 V-PATCH 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 Key6996688
MDR Text Key177456615
Report Number3011175548-2017-00234
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080688
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 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2016
Device Model Number31202
Device Catalogue Number31202
Device Lot Number10910297
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 Received11/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2013
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: 11/02/2017 Patient Sequence Number: 1
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