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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 Insufficient Information (3190)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 11/22/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.
 
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Manufacturer Narrative
Investigation: a review of the manufacturing lot history and sterilization records was conducted. The release criteria was met.
 
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. It was alleged that during a follow-up doctor visit it was noticed swelling, redness, pain, and warmth at the incision site and that the mesh was removed. Also, it was alleged that during removal inflammatory changes were noted. 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
Manufacturer Contact
theresa morin
5 wentworth drive
hudson, NH 03051
6038645237
MDR Report Key4972851
MDR Text Key13520055
Report Number1219977-2015-00229
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2016
Device Model Number31202
Device Catalogue Number31202
Device Lot Number10870369
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/09/2013
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: 08/05/2015 Patient Sequence Number: 1
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