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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 09/08/2015
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Patient had mesh implanted for umbilical hernia repair. Several site swabs sent to pathology revealed infection. Course of antibiotics (flagyl) completed on (b)(6) 2015 surgeon reported site redness; improving.
 
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Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5270916
MDR Text Key32790846
Report Number1219977-2015-00335
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2017
Device Model Number31200
Device Catalogue Number31200
Device Lot Number210640
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/21/2014
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: 12/07/2015 Patient Sequence Number: 1
Treatment
ABSORBABLE TACKS
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