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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 31610
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Abdominal Pain (1685); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240)
Event Date 02/03/2016
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 pain, nausea and vomiting.
 
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, plaintiff presented for severe abdominal pain, nausea, and vomiting. Allegedly, plaintiff was found to have an incarcerated hernia with small bowel obstruction and plaintiff underwent repair surgery, during which it was noted the mesh was adherent to the small bowel and omentum. 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 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
5 wentworth drive
hudson NH 03051
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6142093
MDR Text Key109804222
Report Number1219977-2016-00241
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
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2016
Device Model Number31610
Device Catalogue Number31610
Device Lot Number10880310
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 Received11/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2013
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: 12/02/2016 Patient Sequence Number: 1
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