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

Model Number	1010306-06
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
Event or Problem Description
User reported having problems following implant of mesh.
Additional Manufacturer Narrative
The prolite mesh was not returned as the device had been implanted.Multiple attempts to obtain further information was unsuccessful.Based on the investigation atrium medical corporation cannot conclude that the device was faulty.Without any further information it is impossible to determine the root cause of the complaint.This lot of prolite mesh met all quality and performance requirements based on the review of the device history records and inspection data.Clinical evaluation: prolite is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.The instructions for use (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.

• Brand Name: PROLITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9614238
• Report Number: 3011175548-2020-00086
• Device Sequence Number: 13590165
• Product Code: FTL
• UDI-Device Identifier: 00650862302080
• UDI-Public: 00650862302080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 03/01/2022
• Device Model Number: 1010306-06
• Device Catalogue Number: 1010306-06
• Device Lot Number: 412298
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/24/2020
• 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