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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 31636
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 11/08/2013
Event Type  Injury  
Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirement.
 
Manufacturer Narrative
We are unable to fully investigate this event 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.
 
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 revision surgery on her ventral hernia. Allegedly, during surgery it was noticed that the mesh was dislodged, rolled over and/or permitted ingrowth of the small bowel to the mesh and fixation of the mesh to the abdominal wall, requiring resection of the small bowel and removal of the mesh. 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 Key6142085
MDR Text Key110113302
Report Number1219977-2016-00240
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 11/22/2016
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 Date09/30/2013
Device Model Number31636
Device Catalogue Number31636
Device Lot Number10698747
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/07/2010
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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