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Global Men´s Health Replacement Warranty Policy

Key Features of the Warranty:

Global Coverage: The warranty applies to the following devices, regardless of the territory where it is implanted:

- N&S Testicular implant

- TUBE Malleable penile prosthesis

- VICTO adjustable artificial sphincter

- ARGUS adjustable suburethral system

- VULKO Retropubic adjustable suburethral system (LATAM)

hereinafter: “device”

Five-Year Duration: The warranty term is for a period of five (5) years from the implantation date.

Validity: Effective for devices implanted from 01.04.2024.

Replacement Guarantee: In the event of a device malfunction, during the term of this warranty, the replacement will only proceed if the root cause is related to a manufacturing defect.

Procedure: After the malfunction is detected and the device is explanted, the incident must be notified by the distributor (Promedon´s subsidiaries included) in the Promedon Incident Report System (PIRS) uploading detailed information regarding the incident. Promedon will request the return of the defective device to evaluate the root cause of the problem. The Distributor or Promedon subsidiary must ship the device at their own costs. Once the explanted device is received, it becomes property of Promedon.

After the reception of the device, Promedon will analyze the case and inform the related Distributor if the warranty applies, within the period established in the incident report system.

In the case that the warranty applies, Promedon commits to replace the defective device with a new and functional one free of charge (same or newer version of the device).

Exclusions: This warranty does not cover damages or alterations, prior or during the implantation surgery, caused by improper use, mishandling, negligence, accidents, unauthorized modifications, or any other circumstances beyond Promedon´s reasonable control but only the replacement of the device with a malfunction.

Responsibility: The responsibility to comply with all applicable protocols or reimbursement requirements related to this notice, will be from the recipient of the replaced Device.

At Promedon, we are dedicated to maintaining the highest quality standards in all our manufacturing processes. Our products undergo rigorous testing to ensure durability, reliability, and safety. This warranty serves as a testament to our confidence in the quality of our medical devices and our commitment to customer satisfaction.