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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION MESH C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31201 - C-QUR V PATCH MEDIUM 2.5X2.5 (6.4CM)
Device Problem Material Deformation (2976)
Patient Problems Inflammation (1932); Pain (1994)
Event Type  Injury  
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

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 adipose tissue, harden mesh, chronic pain, chronic foreign body response, failure of incorporation/ingrowth, scarification, fibrosis, mesh deformation, excessive and chronic inflammation, adhesions, recurrence and additional 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.

 
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Brand NameMESH C-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
40 continental blvd
merrimack, NH 
MDR Report Key11382670
MDR Text Key233726179
Report Number3011175548-2021-00226
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 02/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/25/2020
Device MODEL Number31201 - C-QUR V PATCH MEDIUM 2.5X2.5 (6.4CM)
Device Catalogue Number31201
Device LOT Number420615
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/12/2017
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: 02/25/2021 Patient Sequence Number: 1
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