BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFFIRM

    MDR report key: 3391044 · Received October 3, 2013

    Report

    Report Number
    1222993-2013-00008
    Event Type
    Other
    Date Received
    October 3, 2013
    Date of Event
    August 20, 2013
    Report Date
    September 24, 2013
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K081324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN REPORTED THAT THE LASER WAS AT MAXIMUM POWER AT START UP. THE LASER WAS INSPECTED BY SERVICE AND WAS FOUND TO BE IN SPECIFICATION. DURING DISCUSSION BETWEEN THE FIELD SERVICE TECHNICIAN AND THE TREATING PHYSICIAN, THE PHYSICIAN SAID HE DID NOT CHECK THE POWER SETTINGS PRIOR TO DOING THE TREATMENT.

    Description of Event or Problem · 1

    PATIENT RECEIVED A BURN ON THE UPPER LIP DURING AN AESTHETIC LASER PROCEDURE. PHYSICIAN STATED THAT THE LASER WENT TO MAXIMUM POWER WHEN IT WAS TURNED ON. PATIENT WAS PRESCRIBED VALTEX 1G BY THE TREATING PHYSICIAN. HOWEVER, THE PATIENT DECLINED TO BE SEEN BY THE PHYSICIAN AND DECLINED TO FILL THE PRESCRIPTION AND FOLLOW UP WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500542 AFFIRM DERMATOLOGY LASER SYSTEM GEX CYNOSURE, INC. AFFIRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention