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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Seroma (2069)
Event Date 09/09/2014
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
Allegedly, patient also experienced inflammation.
 
Manufacturer Narrative
A thorough investigation was not able to be performed as no product code, lot number, or sample was provided. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered 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 medical's mesh product. Allegedly, after the mesh was implanted for hernia repair, plaintiff developed seroma. Upon removal surgeon encountered a sclerotic area of tissue, along with underlying tissue inflamed but not infected in appearance. Cultures taken at the time of removal showed no evidence of infection. 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
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 Key5937063
MDR Text Key118035024
Report Number1219977-2016-00193
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090909
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 09/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Model Number31202
Device Catalogue Number31202
Device Lot Number203053
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 Received10/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2008
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: 09/08/2016 Patient Sequence Number: 1
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