BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTREUM LASER/IPL

    MDR report key: 5738118 · Received June 21, 2016

    Report

    Report Number
    3011593504-2016-00001
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    November 12, 2015
    Report Date
    March 28, 2016
    Manufacturer
    ROHRER AESTHETICS, LLC
    Product Code
    GEX
    PMA / PMN Number
    K123777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    OUR CUSTOMER, (B)(6), CALLED US ON (B)(6) 2015 TO TELL US HE THINKS HE MAY HAVE BEEN TOO AGGRESSIVE WITH A PATIENT DURING A TATTOO REMOVAL TREATMENT. MR. (B)(6) ASKED US TO COME INSPECT AND CHECK THE POWER ON THE SPECTRUM LASER/IPL HE PREVIOUSLY PURCHASED. MR. (B)(6) TOLD US ON (B)(6) 2015 THAT THE PATIENT WOULD BE FINE AND THERE WOULD BE NO FURTHER ISSUES BUT HE WANTED TO MAKE SURE THE DEVICE WAS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392112 SPECTREUM LASER/IPL MULTI-PLATFORM LASER/IPL GEX ROHRER AESTHETICS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention