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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Pain (1994); Hernia (2240); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.

 
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 chronic wound infection, mesh infection, multiple surgeries to remove hernia mesh, adhesions, abdominal wall abscesses, open draining wound, chronic draining sinus, hernia recurrence, deformity of periumbilical region. 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

Review of medical records reveals this device was not implanted.

 
Event Description

N/a.

 
Search Alerts/Recalls

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Brand NameC-QUR MOSAIC
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 Key7928690
MDR Text Key122447259
Report Number3011175548-2018-01103
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 10/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated By Manufacturer? No
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: 10/02/2018 Patient Sequence Number: 1
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