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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 31636
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Adhesion(s) (1695); Hematoma (1884); 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. Device evaluated by manufacturer? 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 adhesions, bowel obstruction, and hematoma. 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 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 Key10394488
MDR Text Key202504183
Report Number3011175548-2020-01028
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 08/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2017
Device MODEL Number31636
Device Catalogue Number31636
Device LOT Number206538
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/03/2014
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: 08/11/2020 Patient Sequence Number: 1
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