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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH C-QUR; MESH, SURGICAL, POLYMERIC
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ATRIUM MEDICAL CORPORATION MESH C-QUR; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31526
Health Effect - Clinical Code Hernia (2240)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.Not returned.
 
Event or Problem 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 an atrium medical mesh product.Plaintiff allegedly experienced recurrence as a result of the implantation of the mesh implant.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 Name
MESH C-QUR
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
MDR Report Key10833010
Report Number3011175548-2020-01355
Device Sequence Number17146654
Product Code FTL
UDI-Device Identifier00650862315264
UDI-Public00650862315264
Combination Product (Y/N)N
Initial Reporter StateOH
PMA/510(K) Number
K050311
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number31526
Device Catalogue Number31526
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/29/2020
Supplement Date Received by Manufacturer02/01/2021
Initial Report FDA Received Date11/12/2020
Supplement Report FDA Received Date02/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age57 YR
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