BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA

    MDR report key: 19998701 · Received August 15, 2024

    Report

    Report Number
    MW5158528
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Report Date
    August 13, 2024
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619998 VERSA IMPLANT, DERMAL, FOR AESTHETIC USE LMH PROLLENIUM MEDICAL TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other