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

Model Number	1000204-01
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
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.Plaintiff allegedly experienced unspecified injuries and complications as a result of the implantation of the mesh implant.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.

• Brand Name: MESH PROLITE PRESHAPES
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10460316
• Report Number: 3011175548-2020-01069
• Device Sequence Number: 2147287
• Product Code: FTL
• UDI-Device Identifier: 00650862300239
• UDI-Public: 00650862300239
• Combination Product (Y/N): N
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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 Date: 01/21/2021
• Device Model Number: 1000204-01
• Device Catalogue Number: 1000204-01
• Device Lot Number: 404272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR