BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUE RF WITH COOLPEEL

    MDR report key: 11874718 · Received May 24, 2021

    Report

    Report Number
    MW5101514
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 20, 2021
    Manufacturer
    CARTESSA AESTHETICS
    Product Code
    OUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A MICRO-NEEDLING RF WITH COOL PEEL PROCEDURE CONDUCTED ON 5/10 USING CARTESSA VIRTUE RF. PER LITERATURE 24 HOUR RECOVERY WITH LITTLE TO NO SIDE EFFECTS EXPECTED. POST DAY 1 I HAD EXTREME EDEMA AND POST DAY 2 EDEMA IN MY FACE WORSENED SO MUCH SO THAT IT WAS OBSTRUCTING MY VISION. DERMATOLOGIST PRESCRIBED A MEDROL DOSE PACK. DAY 8 SWELLING ABATED BUT LEFT WITH ERYTHEMA, HYPERPIGMENTATION AND TRACK MARKS FROM THE DEVICE. PRESCRIBED TOPICAL STEROID, BURN OINTMENT AND HYDROQUINONE AND TOLD TO ABSTAIN FROM ANY SUN EXPOSURE FOR THE NEXT 3 MONTHS. UNSURE IF I WILL BE LEFT WITH SCARRING OR HYPERPIGMENTATION. I CAN PROVIDE PICTURES IF NECESSARY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765372 VIRTUE RF WITH COOLPEEL SKIN RESURFACING RF APPLICATOR OUH CARTESSA AESTHETICS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR