BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE

    MDR report key: 2252012 · Received September 16, 2011

    Report

    Report Number
    3004135191-2011-00047
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 16, 2011
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED WITHIN MANUFACTURER SPECIFICATIONS. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS, PATIENT CLINICAL RECORD, AND PATIENT PHOTOGRAPHS CONCLUDING THAT TREATMENT SETTINGS WERE MILDLY AGGRESSIVE, HOWEVER, BASED ON THE PATIENT'S PHOTOGRAPHS THE PROBABLE CAUSE OF THE REPORTED ADVERSE OUTCOME WAS A BACTERIAL INFECTION. THE HEALTHCARE PROFESSIONAL STATED THAT THE USE OF ZITHROMAX IS NOT RECOMMENDED CONSIDERING THE MOST COMMON CAUSE OF INFECTION IS USUALLY A GRAM NEGATIVE BACTERIUM. THE HEALTHCARE PROFESSIONAL STATED THAT BASED ON PUBLISHED EXPERIENCE WITH INFECTIONS AFTER LASER RESURFACING TREATMENT, THE USE OF CIPROFLOXACIN OR OTHER QUINOLONE ANTIBIOTIC IS SUGGESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED SCARRING TO THE FACE FOLLOWING TREATMENTS WITH A LUMENIS ULTRAPULSE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASER GEX LUMENIS, LTD. ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other VALTREX| ZITHROMAX