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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31531
Device Problem Material Separation (1562)
Patient Problems Adhesion(s) (1695); Respiratory Distress (2045); Hernia (2240); Obstruction/Occlusion (2422)
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 recurrent hernia, pain, vomiting, bowel obstruction, fluid retention, adhesions, separation of mesh, and respiratory distress. 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

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.

 
Event Description

Plaintiff also allegedly experienced incarceration.

 
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Brand NameC-QUR MESH
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 Key8633590
MDR Text Key145847953
Report Number3011175548-2019-00590
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2016
Device MODEL Number31531
Device Catalogue Number31531
Device LOT Number10872885
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/21/2013
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: 05/22/2019 Patient Sequence Number: 1
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