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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MOSAIC MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31105
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted on completion of the investigation into this event.
 
Event Description
Received a report that a patient had mesh implanted for lap ventral hernia repair. Patient went back to hospital within one or two days complaining of abdominal pain. Patient had a scan and doctor stated it was probably due to blood in the abdomen.
 
Manufacturer Narrative
A review of lot history and sterilization records was performed. The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre & post sterile pouches. All raw materials met all incoming testing and inspections. Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release. Clinical evaluation: laparoscopic hernia repair uses an instrument called a laparoscope. Between two and four small incisions are made through the abdominal wall through which are passed the laparoscope and surgical instruments into the abdomen. The hernia is then viewed from inside the abdomen. The abdominal cavity is inflated with carbon dioxide gas to give the surgeon space to work inside the patient and the actual operating is done remotely with long instruments. The hernia defect or hole is covered with mesh from within the abdomen and staples commonly fired through it into the muscle tissue in order to fix it as a patch. Pain is a recognized complication of many common procedures including laparoscopic hernia repair. Surgical technique can influence the development of post-surgical pain and techniques to minimize nerve injury should be used whenever possible. The instructions for use state, "complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection and pain. " the fixation technique, method, and products used, including sutures, tacks, etc. ) is left to the discretion of the surgeon to optimize clinical outcomes.
 
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Brand NameC-QUR MOSAIC 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
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5727326
MDR Text Key47487770
Report Number1219977-2016-00133
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Model Number31105
Device Catalogue Number31105
Device Lot Number216294
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 Received07/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2014
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: 06/15/2016 Patient Sequence Number: 1
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