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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31626
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Adhesion(s) (1695); Perforation (2001); Hernia (2240)
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 hernia recurrence, adhered to small bowel, and serosal tears. 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 component separation, scar tissue and partial omentectomy.

 
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Brand NameC-QUR TACSHIELD
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 Key9105182
MDR Text Key162344335
Report Number3011175548-2019-01019
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2014
Device MODEL Number31626
Device Catalogue Number31626
Device LOT Number10738105
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/06/2011
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: 09/23/2019 Patient Sequence Number: 1
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