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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31633
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Foreign Body Reaction (1868)
Event Type  Injury  
Manufacturer Narrative
A thorough investigation was not able to be performed as no product code, lot number, or sample was provided. A review of complaints was performed and there have not been any similar reports related to a device malfunction. 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.
 
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Manufacturer Narrative
The lot history records and sterilization records were reviewed. The lot history information showed that the lot was sterilized acceptably, and that the device was manufactured and released according to the appropriate manufacturing procedures and relevant specifications.
 
Event Description
This event is deemed reportable based on the allegations in a lawsuit, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product. Plaintiff was allegedly implanted with a mesh and suffered an adverse reaction (foreign body). Allegedly an abdominal mass was removed which was noted to be contracted mesh and cultures taken at time of removal indicated no 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 TACSHIELD
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
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key4915637
MDR Text Key13974350
Report Number1219977-2015-00192
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100076
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 07/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2014
Device Model Number31633
Device Catalogue Number31633
Device Lot Number10736905
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 Received02/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2011
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: 07/15/2015 Patient Sequence Number: 1
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