BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHRER AESTHETICS BODY SCULP

    MDR report key: 21059427 · Received January 2, 2025

    Report

    Report Number
    MW5164178
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 20, 2024
    Report Date
    December 27, 2024
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    PKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE ROHRER AESTHETICS BODY SCULP MACHINE SHOULD NOT BE APPROVED. HAD SERIOUS BURNS FROM THE INSIDE OUT AND IT FELT LIKE TORTURE DURING TREATMENT. WHEN THEY OFFER YOU LAUGHING GAS TO GET THROUGH THE PAIN, YOU KNOW THERE IS A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431558 ROHRER AESTHETICS BODY SCULP LASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE PKT ROHRER AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other