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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION MESH C-QUR TACHSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31610
Device Problem Material Deformation (2976)
Patient Problems Pain (1994); Swelling (2091); Hernia (2240)
Event Type  Injury  
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. Device evaluated by manufacturer? not returned.

 
Event Description

This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product. Plaintiff allegedly experienced hernia recurrence, pain, swelling, crumpled mesh, and mental anguish. Since this is a potential 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 NameMESH C-QUR TACHSHIELD
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 Key10797064
MDR Text Key215012371
Report Number3011175548-2020-01334
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
Report Date 11/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/01/2019
Device MODEL Number31610
Device Catalogue Number31610
Device LOT Number408289
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/16/2016
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: 11/05/2020 Patient Sequence Number: 1
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