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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 1001212-00
Health Effect - Clinical Code Hernia (2240)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirement.
 
Event or Problem 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 unspecified injuries and complications as a result of the implantation of the mesh implant.
 
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Brand Name
MESH PROLITE SHEETS
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
MDR Report Key10947038
Report Number3011175548-2020-01412
Device Sequence Number3190109
Product Code FTL
UDI-Device Identifier00650862300109
UDI-Public00650862300109
Combination Product (Y/N)N
PMA/510(K) Number
K002093
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/03/2020
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 Expiration Date04/30/2015
Device Model Number1001212-00
Device Catalogue Number1001212-00
Device Lot Number10628215
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/17/2020
Initial Report FDA Received Date12/04/2020
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 Age66 YR
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