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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
Device Problems Expulsion (2933); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); 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 surgeries, chronic pain, hernia recurrence, revision on (b)(6) 2018, mesh dehiscence, infection, adhesions and bowel resection. 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
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
40 continental blvd
merrimack, NH 
MDR Report Key11713262
MDR Text Key249646854
Report Number3011175548-2021-00440
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 04/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/23/2021 Patient Sequence Number: 1
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