BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER GENESIS

    MDR report key: 11444391 · Received March 8, 2021

    Report

    Report Number
    MW5099845
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    October 1, 2020
    Report Date
    March 4, 2021
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO RENEW MEDISPA FOR MY 4TH LASER GENESIS (FROM CUTERA) TREATMENT FOR A SCAR. ABOUT AN HOUR AFTER THE TREATMENT, BLISTERS FORMED ALONG THE TREATMENT AREA AND I SUSTAINED A SECOND DEGREE BURN. I CONTACTED THE MEDI SPA, SAW WOUND CARE AND WAS TREATED FOR SECOND DEGREE BURNS FROM LASER GENESIS. I AM CURRENTLY STILL UNDERGOING SCAR TREATMENTS FROM THE INJURY THAT OCCURRED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338140 LASER GENESIS POWERED LASER SURGICAL INSTRUMENT GEX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention| S