BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON

    MDR report key: 3984971 · Received July 29, 2014

    Report

    Report Number
    1222993-2014-00029
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 25, 2014
    Product Code
    GEX
    PMA / PMN Number
    K110907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CONSULTED A DERMATOLOGIST THAT PRESCRIBED BIOFIN CREAM AND WAS INFORMATED THAT HE IS NOT BURNT AND HE WILL HEAL WITH NO FURTHER COMPLICATIONS. DEVICE IS BEING SHIPPED BACK TO CYNOSURE INC FOR EVALUATION.

    Description of Event or Problem · 1

    BLISTER AND BURNS ON ARM AFTER TREATMENT OF PIGMENTED LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442804 ICON ICON GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention