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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 31533
Device Problem Detachment Of Device Component (1104)
Patient Problems Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no 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 mesh detachment, re-herniation, pain, and revision surgery. 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 requirement.

 
Event Description

Plaintiff allegedly also experienced adhesions.

 
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Brand NameC-QUR MESH
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 Key7163293
MDR Text Key96331074
Report Number3011175548-2018-00019
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 01/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2014
Device Catalogue Number31533
Device LOT Number10736226
OTHER Device ID Number00650862315332
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/21/2011
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: 01/04/2018 Patient Sequence Number: 1
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