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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 31633
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Adhesion(s) (1695); Fistula (1862); Skin Infection (4544)
Event Type  Injury  
Manufacturer Narrative
Based on the review of the device history and sterilization records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirement. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.
 
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 avulsion from fascia infection, fistula, recurrence, incarceration, adhesions, fluid drainage, wound vac, fascial wound dehiscence with bowel evisceration, enterocutaneous fistula, small bowel resection and enteroenterostomy, ((b)(6) 2014) ultrasound guidance tan fluid collection. 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 TACHSHIELD
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 Key12914346
MDR Text Key281572453
Report Number3011175548-2021-01215
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2016
Device Model Number31633
Device Catalogue Number31633
Device Lot Number10877160
Was Device Available for Evaluation? No
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/21/2013
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/01/2021 Patient Sequence Number: 1
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