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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 Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Hospital reported that they went to open the package on the sterile field for surgery the one side of the package would not open correctly.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8566864
MDR Text Key143683308
Report Number3011175548-2019-00489
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 04/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2021
Device Model Number31544
Device Catalogue Number31544
Device Lot Number438312
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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