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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR MOSAIC MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31107
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative

Upon completion of the investigation a follow up report will be submitted.

 
Event Description

Surgeon used c-qur mosaic mesh for a lap ventral hernia. A few of the sorbafix tacks went through the entire mesh failing to fixate to the tissue. The mesh was left in the patient, as most of the tacks were fixated properly, 45 in total.

 
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Brand NameC-QUR MOSAIC 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 Key7542087
MDR Text Key109182783
Report Number3011175548-2018-00522
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK121070
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 05/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/07/2020
Device MODEL Number31107
Device Catalogue Number31107
Device LOT Number424777
OTHER Device ID Number00650862311075
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 Received05/29/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/21/2017
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: 05/24/2018 Patient Sequence Number: 1
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