BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM LASER/IPL

    MDR report key: 7531655 · Received May 22, 2018

    Report

    Report Number
    3011593504-2018-00002
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 21, 2018
    Manufacturer
    ROHRER AESTHETICS, LLC
    Product Code
    GEX
    UDI-DI
    0100860564000317
    PMA / PMN Number
    K123777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2018, WE WERE MADE AWARE OF A POSSIBLE INCIDENT USING THE IPL HANDPIECE ON THE SPECTRUM LASER. THE USER, (B)(6), CLAIMS THAT A PATIENT WAS BURNED WHILE USING THE IPL AT A LOW SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374862 SPECTRUM LASER/IPL SPECTRUM LASER/IPL GEX ROHRER AESTHETICS, LLC 0100860564000317

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention