BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTERA, INC.

    MDR report key: 2177049 · Received December 2, 2008

    Report

    Report Number
    2177049
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 25, 2008
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT RECEIVED LASER TREATMENT ON NECK. PT NOTIFIED PROVIDER ON (B)(6) 2008 THAT HE WAS EXPERIENCING PAIN AND BURNS AT AREA OF TREATMENT. A 10MM BURN EVALUATED. LASER CUTERA COOLGLIDE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTERA, INC. LASER, ND: YAG GEX CUTERA, INC. US220EXCL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other LASER CUTERA COOLGLIDE ND: YAG 1064