inforMED
MalfunctionLMH

VERSA

Received Aug 15, 2024

Report MW5158528 · MDR key 19998701

Device

Generic name

Implant, Dermal, For Aesthetic Use

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PROLLENIUM IS INCENTIVIZING REPS TO SELL ITS PRODUCT VERSA FOR OFF-LABEL INDICATION. SOME REPS, INCLUDING THE GM ARE GETTING MONETARY INCENTIVE - COMMISSION AND OR BONUS FOR SELLING OFF LABEL TO PHALOFIL. PHALLOFIL EXCLUSIVELY PERFORMS PENILE ENHANCEMENT AND PROLLENIUM SELLS HEAVILY TO THEM. THE PROBLEM IS THAT REPS AND GM ARE MAKING A SIGNIFICANT AMOUNT OF COMMISSION KNOWING THAT THIS IS OFF LABEL. EMPLOYEES WHO REPORTED THIS TO MANAGEMENT WERE FIRED. ASK TO SAY THE COMMISSION REPORTS AND BACK UP DATA FOR (B)(4).