• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORP. C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Event Type  Injury  
Event Description

Mesh removed 12 days after surgery. The pt had pain and intestinal occlusion. Underwent laparotomy and found the mesh attached to several loops of small intestine. Culture results came back negative for infection.

 
Manufacturer Narrative

We are in the process of performing the investigation and will submit the f/u report once the eval is completed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR TACSHIELD
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson , NH 03051
6038645237
MDR Report Key4107017
Report Number1219977-2014-00300
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/13/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/13/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/11/2014 Patient Sequence Number: 1
Treatment
PERMANENT TACKS
-
-