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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORP. C-QUR MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Obstruction/Occlusion (2422)
Event Date 08/19/2011
Event Type  Death  
Event Description
This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable events may have occurred during use of atrium medicals mesh product.Plaintiff alleges that after hernia surgery and mesh implantation a pt had recurrent incisional hernia.It was also alleged that later the pt developed other issues, had other surgeries and expired.Since this is a legal matter, the case has been turned over to legal counsel and further info obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if add'l info comes to its attention.
 
Manufacturer Narrative
A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.This report is based upon allegations made in a lawsuit in which atrium medical is named defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit and described herein are or were defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.
 
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Brand Name
C-QUR MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
4038645237
MDR Report Key4109388
MDR Text Key21318092
Report Number1219977-2014-00307
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 08/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/28/2014
Initial Date FDA Received09/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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