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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 Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Blood Loss (2597)
Event Date 01/22/2014
Event Type  Injury  
Event Description
Allegedly patient also experienced incisional hernia, adhesions, inflammation, non-healing wounds and bleeding.
 
Manufacturer Narrative
A thorough investigation was not able to be performed as no product code, lot number, or sample was provided. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit and described herein are or were defective, or that it had any casual relationship to any injuries allegedly sustained 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 medicals mesh product. Allegedly, after the mesh was implanted for ventral hernia repair, plaintiff had mesh removed due to 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.
 
Manufacturer Narrative
A review of all manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile packaging. Ball burst and suture retention testing was also conducted on the mesh at incoming and fourier transform infrared spectroscopy was performed on the cured coated mesh panels.
 
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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 Key5398033
MDR Text Key118034592
Report Number1219977-2016-00019
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,Followup
Report Date 09/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2015
Device Model Number31202
Device Catalogue Number31202
Device Lot Number10846124
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 Received10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2012
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: 01/29/2016 Patient Sequence Number: 1
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