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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH PROLITE SHEETS MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION MESH PROLITE SHEETS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000306-00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
Investigation: 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 potential lawsuit in which atrium medical would be named as a defendant.
 
Event Description
This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product. Plaintiff allegedly experienced infection, draining sinus tracts, pain, tenderness, scar tissue, granulation tissue, purulence, induration, failed antibiotic management, debridement, incorporated and unincorporated mesh. Since this is a potential 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 PROLITE SHEETS
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 Key13020545
MDR Text Key282379058
Report Number3011175548-2021-01321
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002093
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000306-00
Device Catalogue Number1000306-00
Device Lot Number428553
Was Device Available for Evaluation? No
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/07/2018
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
Treatment
ANTIBIOTIC TREATMENTS
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