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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31106
Device Problem Positioning Problem (3009)
Patient Problems Discharge (2225); Hernia (2240); Ascites (2596)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided. Not returned.

 
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 lax and redundant mesh, large protruding mass, additional surgery, incarcerated hernia, and recurrent hernia. 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.

 
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Brand NameC-QUR MOSAIC
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 Key10146704
MDR Text Key194924556
Report Number3011175548-2020-00788
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 OTHER
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2017
Device MODEL Number31106
Device Catalogue Number31106
Device LOT Number205701
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/06/2014
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: 06/11/2020 Patient Sequence Number: 1
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