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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
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Type  Injury  
Event Description
Doctor reported he had used mesh for hernia repair and pt developed an infection.Large seroma became infected after several weeks post surgery, treated with antibiotics.
 
Manufacturer Narrative
We are unable to perform a full investigation as no sample, product code or lot number was available.Review of complaints does not show any similar reports related to a device failure.If any further info is provided a follow up report will be submitted.The other seven reports are: 1219977-2014-00036, 1219977-2014-00037, 1219977-2014-00038, 1219977-2014-00039, 1219977-2014-00040, 1219977-2014-00041, 1219977-2014-00043.
 
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Brand Name
C-QUR V-PATCH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
theresa morin, complaints manager
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3687785
MDR Text Key20324989
Report Number1219977-2014-00042
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/20/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2014
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 Received09/20/2013
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 Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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