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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR EDGE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31228
Device Problems Detachment Of Device Component (1104); Degraded (1153); Material Rupture (1546)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Anxiety (2328); Injury (2348)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.

 
Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product. Plaintiff allegedly experienced pain, discomfort, mesh separation, recurrent hernia, ruptured mesh, colon adhesions, explanation of mesh, risk and anxiety of surgery, weakened mesh and related comorbidities. Since this is a legal matter, the case has been turned over to legal counsel and further information 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 additional information comes to its attention.

 
Manufacturer Narrative

Investigation: based on the review of the device history records and product complaint details, atrium can find no fault with the product. This lot of mesh passed all quality and performance requirements.

 
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Brand NameC-QUR EDGE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
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 Key7402297
MDR Text Key104539321
Report Number3011175548-2018-00316
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK080691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2010
Device MODEL Number31228
Device Catalogue Number31228
Device LOT Number10298927
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Device Age yr
Event Location No Information
Date Manufacturer Received04/11/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/23/2008
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: 04/06/2018 Patient Sequence Number: 1
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