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

Model Number	1000609-00
Health Effect - Clinical Codes	Fatigue (1849); Failure of Implant (1924); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.
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 pain, tenderness, discomfort, scar tissue, recurrent hernia, adherence to tissue/organs, infection, nerve damage and additional surgery.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.
Additional Manufacturer Narrative
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 requirements.
Event or Problem Description
N/a.

• Brand Name: PROLITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8260684
• Report Number: 3011175548-2019-00091
• Device Sequence Number: 1616644
• Product Code: FTL
• UDI-Device Identifier: 00650862300246
• UDI-Public: 00650862300246
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K002093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 06/30/2018
• Device Model Number: 1000609-00
• Device Catalogue Number: 1000609-00
• Device Lot Number: 10897361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: 42 YR