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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Received a report of a problem during implantation having difficulty with tacking. User feels that the mesh is "thinner" than it used to be.
 
Manufacturer Narrative
Analysis - as the device in question was not returned and the lack of the product lot number atrium medical cannot conduct a thorough investigation. There have been no changes to the mesh in regards to the thickness of the material. Summary/conclusion - based on the details of the complaint, atrium medical cannot conclude that the mesh was thinner. Atrium medical has not changed the thickness of the mesh material. Clinical evaluation - c-qur mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. Problems after hernia repair are usually related to using a mesh product that is too small or to the fixation method and technique. It may also be related to non-compliance with activity limitations post operatively. Other factors that contribute to the outcome of hernia repairs are the patient's weight and medical comorbidities such as morbid obesity, diabetes and a history of smoking. The instructions for use (ifu) states 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
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7819879
MDR Text Key118344301
Report Number3011175548-2018-00930
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
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 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
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 Received09/25/2018
Was Device Evaluated by Manufacturer? No
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: 08/27/2018 Patient Sequence Number: 1
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