MalfunctionLMH
VERSA
Received Aug 15, 2024
Report MW5158528 · MDR key 19998701
Device
Generic name
Implant, Dermal, For Aesthetic Use
Manufacturer
Prollenium Medical Technologies Inc.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).