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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MESH PROLITE ULTRA SHEETS; MESH, SURGICAL, POLYMERIC
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MESH PROLITE ULTRA SHEETS; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30717
Health Effect - Clinical Code No Information (3190)
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.Not returned.
 
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.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 Name
MESH PROLITE ULTRA SHEETS
Common Device Name
MESH, SURGICAL, POLYMERIC
MDR Report Key10022939
Report Number3011175548-2020-00613
Device Sequence Number2937911
Product Code FTL
UDI-Device Identifier00650862307177
UDI-Public00650862307177
Combination Product (Y/N)N
PMA/510(K) Number
K002093
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/04/2020
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 Date04/30/2020
Device Model Number30717
Device Catalogue Number30717
Device Lot Number400504
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/22/2020
Initial Report FDA Received Date05/04/2020
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 Age61 YR
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