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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 31544
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hernia (2240)
Event Date 08/26/2015
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Patient developed a hernia when she was first pregnant and had difficult labor resulting in an emergency c-section. It was noted to the doctor that it was a sizable hernia. Hernia was repaired with mesh in (b)(6) 2014. In (b)(6) 2015, the mesh was removed due to hernia recurrence.
 
Manufacturer Narrative
Investigation: lot history records were reviewed. The mesh rolls used to manufacture this mesh lot met specification for suture retention strength and ball burst strength. The lot records showed that the fish oil passed all analytical testing. Fourier-transform infrared spectrophotometer test records showed that the mesh coating had adequate crosslinking. Sterilization records show that the lot passed sterilization requirements. The packaged finished goods met the pouch peel test acceptance requirements. Based on the lot records, 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: a patient who experiences a recurrence of their hernia will need further surgical intervention. Recurrence after mesh repair may be caused by inadequate mesh size, incorrect mesh fixation, poor overlap, stress on the mesh and inadequate dissection and exploration of the hernia site. Hernia recurrence is an event that may happen with the implant of any surgical mesh and is one of the risks considered during the conversation between physician and patient when discussing potential treatment options. The instructions for use state that "adequate mesh fixation is required to minimize post-operative complications and recurrence. The fixation technique, method and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes. ".
 
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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 Key5056723
MDR Text Key25021680
Report Number1219977-2015-00263
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2016
Device Model Number31544
Device Catalogue Number31544
Device Lot Number10886989
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2013
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: 09/04/2015 Patient Sequence Number: 1
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