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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
Event Type  Injury  
Event Description

Received report of doctor has performed five cases using tachshield and had two events of infection.

 
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.

 
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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
Report Number1219977-2014-00093
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Physician
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 Health Professional
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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