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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP C-QUR V-PATCH
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ATRIUM MEDICAL CORP C-QUR V-PATCH Back to Search Results
Model Number 31202
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Fistula (1862)
Event Date 07/31/2012
Event Type  Injury  
Event Description
Chronic fistula between mesh and umbilicus.Explanted 4 months post surgery.
 
Manufacturer Narrative
This event was reported during a study on v-patch in (b)(6).Reports 1219977-2014-00005, 1219977-2014-00006, and 1219977-2014-00007 are the other three files that were a part of the study.Upon completion of the investigation a follow up report will be submitted.
 
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Brand Name
C-QUR V-PATCH
Manufacturer (Section D)
ATRIUM MEDICAL CORP
hudson NH
Manufacturer Contact
thersa morin, complaints mgr
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3632495
MDR Text Key3991062
Report Number1219977-2014-00008
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2014
Device Model Number31202
Device Catalogue Number31202
Device Lot Number10808442
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/04/2012
Initial Date FDA Received02/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2011
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) Required Intervention;
Patient Age56 YR
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