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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH

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ATRIUM MEDICAL CORP. C-QUR MESH Back to Search Results
Model Number 31526
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994)
Event Date 01/07/2011
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Received a medwatch stating that pt underwent a repair of hernia. Pt reported further surgeries due to pain, adhesions and mesh rejection. (b)(4).
 
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Brand NameC-QUR MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key4811381
MDR Text Key13387478
Report Number1219977-2015-00158
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 Other
Type of Report Initial
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date06/30/2013
Device Model Number31526
Device Catalogue Number31526
Device Lot Number10659442
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2010
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: 06/01/2015 Patient Sequence Number: 1
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