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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR TACHSHIELD MESH

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ATRIUM MEDICAL CORPORATION C-QUR TACHSHIELD MESH Back to Search Results
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
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 details are provided a follow up report will be submitted. The other report is: 1219977-2014-00092.
 
Event Description
Received report of doctor has performed five cases using tachshield and had two events of infection.
 
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Brand NameC-QUR TACHSHIELD MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer Contact
theresa morin, mgr
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3687873
MDR Text Key11666807
Report Number1219977-2014-00093
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/01/2012
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2012
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: 02/28/2014 Patient Sequence Number: 1
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