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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31201
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Pain (1994); 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. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.
 
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 additional surgery, pain, fistula, infection and hernia recurrence. 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 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
lori gosselin
40 continental blvd
merrimack, NH 
MDR Report Key12897833
MDR Text Key281662061
Report Number3011175548-2021-01211
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2016
Device Model Number31201
Device Catalogue Number31201
Device Lot Number10893006
Was Device Available for Evaluation? No
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/07/2013
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/30/2021 Patient Sequence Number: 1
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