BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL

    MDR report key: 2830250 · Received November 6, 2012

    Report

    Report Number
    MW5027556
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    November 6, 2012
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FRAXEL: I WAS TOLD THAT SMALL BUMPS WOULD APPEAR LIKE SKIN-TAGS, BUT GO AWAY. THEY APPEARED, BUT NEVER WENT AWAY ON MY NECK. WHEN I WENT BACK IN TO THE MD TO POINT THIS OUT, HE BLEW ME OFF AND WOULD NOT EVEN ADDRESS THE ISSUE. I WAS ALSO TOLD IT WASN'T PAINFUL BECAUSE THE DOCTOR USED LIDOCAINE TOPICAL. FRANKLY, IT HURT LIKE (B)(4) AND I HAVE A HIGH TOLERANCE TO PAIN. I WAS NOT CAUTIONED ABOUT DRIVING AND I FOUND I HAD TO USE ALL MY CONSIDERABLE PROFESSIONAL DRIVING SKILLS TO GET HOME. CONCLUSION, EVEN IF YOU USE A MD LIKE I DID, GIVE THIS PROCEDURE A PASS. I NOW HAVE TO FIND A COMPETENT DERMATOLOGIST TO TRY TO GET RID OF THE NUMEROUS BUMPS AND SKIN-LIKE TAGS ON MY NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL LASER GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR