Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 CORPORATION C-QUR V-PATCH
  • 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 CORPORATION C-QUR V-PATCH Back to Search Results
Model Number 31202
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Unspecified Infection (1930)
Event Date 06/19/2012
Event Type  Injury  
Event Description
The patient presented with fistulization (connection) between mesh implant and umbilicus and infection 10 days post-operation.
 
Manufacturer Narrative
This event was reported during a study on v-patch in (b)(6).Mdr #s: 1219977-2014-00005, 1219977-2014-00007 and 1219977-2014-00008 are the other three files that were a part of the study.Upon completion of the investigation a follow up report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
C-QUR V-PATCH
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer Contact
theresa morin, mgr
5 wentworth drive
hudson, NH 03051
6038801433
MDR Report Key3632512
MDR Text Key3989607
Report Number1219977-2014-00006
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/04/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2014
Device Model Number31202
Device Catalogue Number31202
Device Lot Number10794356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/04/2012
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ABSORBABLE SUTURES
Patient Outcome(s) Other;
Patient Age49 YR
-
-