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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31528
Device Problem Device Contamination with Chemical or Other Material
Event Date 08/09/2015
Event Type  Injury  
Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

 
Event Description

Received a report of an event that while implanting mesh into the patient a half piece of plastic lining was also implanted. The packaging plastic piece was explanted (b)(6) 2015 and the mesh remains in the patient.

 
Manufacturer Narrative

The mesh rolls used to manufacture this mesh met specification for residual lubricant, suture retention strength and ball burst strength. Fourier-transform infrared spectrophotometry (ftir) test records showed that the mesh coating had adequate crosslinking. Sterilization records show that the lot was released. Packaging was subjected to pre and post sterile pouch seal strength testing, and met the acceptance requirements. Based on the lot information, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture. Clinical evaluation: the handling sleeve facilitates ease handling in the sterile field. The handling sleeve that protects the c-qur mesh product is loosely, but securely place around the device with a seal on each side. The sleeve visually is clear while the mesh is a tan/yellow color. The protective sleeve has a firm, smooth plastic texture while the mesh has a woven texture that is easily discernable from the packaging. The handling sleeve provides to the user tactile, visual and auditory cues that inform the user to remove it prior to implantation. The instructions for use state that "the atrium c-qur mesh must be removed from the handling sleeve using sterile technique prior to use. ".

 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
5 wentworth drive
hudson , NH 03051
6038645237
MDR Report Key5015091
Report Number1219977-2015-00235
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/30/2017
Device MODEL Number31528
Device Catalogue Number31528
Device LOT Number218439
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/20/2014
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: 08/19/2015 Patient Sequence Number: 1
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