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

Model Number	30807
Health Effect - Clinical Codes	Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); 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.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.
Event or Problem 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 personal injury, pain and suffering, severe emotional distress, inguinal hernia, phlegmon, and adhesions.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.

• Brand Name: PROLITE ULTRA
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8348870
• Report Number: 3011175548-2019-00174
• Device Sequence Number: 206993
• Product Code: FTL
• UDI-Device Identifier: 00650862308075
• UDI-Public: 00650862308075
• Combination Product (Y/N): N
• Initial Reporter State: AL
• PMA/510(K) Number: K002093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2019

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: 04/30/2015
• Device Model Number: 30807
• Device Catalogue Number: 30807
• Device Lot Number: 10621808
• Was Device Available for Evaluation?: No
• Device Age: YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/18/2019
• 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: 49 YR