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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MOSAIC MESH

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ATRIUM MEDICAL CORP. C-QUR MOSAIC MESH Back to Search Results
Model Number 31128
Event Date 10/17/2013
Event Type  Injury  
Event Description

An atrium medical sales representative was present during this surgery. She witnessed the doctor roll a piece of mosaic mesh (4x6) on patients abdomen. His chest had been prepped with chlor-a-prep and the mesh was tacked in place using the "absorbatack. " patient presented a rash one week later. The doctor treated it with keflex 500mg tid and it resolved. The rash was in the exact shape of the mesh. Ventral hernia repair. Size of hernia defect 2-6 cm. Laparoscopic. Intraperitoneal. It was not cultured for infection. When the doctor was asked about the event details he told the atrium sales representative that he rolled the mesh on a blue towel.

 
Manufacturer Narrative

A final report will be submitted upon the completed investigation into this event.

 
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Brand NameC-QUR MOSAIC MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
theresa morin, capa manager
5 wentworth dr.
hudson , NH 03051
6038801433
MDR Report Key3538702
Report Number1219977-2013-00193
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 12/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number31128
Device Catalogue Number31128
Device LOT NumberP0130187
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/10/2013
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 Initial

Patient TREATMENT DATA
Date Received: 12/19/2013 Patient Sequence Number: 1
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