• 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 MESH

  • 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 MESH Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)
Event Date 09/20/2012
Event Type  Injury  
Event Description

Home pt reported that she had hernia (belly) surgery using c-qur mesh on (b)(6) 2010. On (b)(6) 2012 was admitted for bowel movement difficulties. Surgery was performed to remove the large intestine. Mesh had grown around the colon. Pt now must use a "bag" for collection.

 
Manufacturer Narrative

A final report will be submitted upon the completed investigation into this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
theresa morin, capa manager
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3405675
MDR Text Key3903526
Report Number1219977-2013-00141
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 09/25/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2013
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? No
Date Manufacturer Received09/25/2013
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: 09/07/2013 Patient Sequence Number: 1
-
-