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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORP. C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description

The physician reported that in the course of implanting mesh, the coating was falling off while attempting to tack the mesh.

 
Manufacturer Narrative

On completion of the investigation, a follow up report will be submitted.

 
Search Alerts/Recalls

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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key4619369
MDR Text Key5766380
Report Number1219977-2015-00086
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2015
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 Received03/05/2015
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: 03/19/2015 Patient Sequence Number: 1
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