BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYNOSURE CELLULAZE - SLT II

    MDR report key: 8313178 · Received February 6, 2019

    Report

    Report Number
    1222993-2019-00003
    Event Type
    Death
    Date Received
    February 6, 2019
    Date of Event
    April 19, 2018
    Report Date
    February 6, 2019
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    OYW
    UDI-DI
    08057017760009
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS MADE AWARE THAT A PATIENT DEATH OCCURRED FOLLOWING A LASER TREATMENT ON THE THIGHS AREA. THIS CLAIM WAS MADE BY THE PATIENT'S BROTHER WHO INDICATED THAT THE DEATH WAS DUE TO BLEEDING. HOWEVER, THE CUSTOMER SITE STATED THE PATIENT'S LASER TREATMENT HAD PROCEEDED NORMALLY AND HER BLOOD PRESSURE WAS IN GOOD STANDING. THE CUSTOMER SITE STATED THAT THE PATIENT DID NOT SHOW UP FOR ANY FOLLOW UP CHECKUPS. PRIOR TO THE LASER TREATMENT, IT WAS DISCLOSED THAT THE PATIENT WAS CURRENTLY TAKING ANTIDEPRESSANT MEDICATIONS. PATIENT WAS ALSO GIVEN ALPRAZOLAM ORALLY FOR SEDATION AND LIDOCAINE/EPINEPHRINE FOR TUMESCENT ANESTHESIA AS PART OF THE PRE-TREATMENT ACTIVITIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER SITE REGARDING THE PATIENT'S DEATH OR TREATMENT PROCEDURE. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATED AS INTENDED WITHIN SPECIFICATION. ONE OF THE EXPECTED SIDE EFFECTS FROM AN SLT II LASER PROCEDURE IS BLEEDING, BUT DUE TO LIMITED INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND PROCEDURE COULD NOT BE DETERMINED FROM THIS INVESTIGATION. THIS IS A REPORTABLE EVENT DUE TO A PATIENT DEATH.

    Description of Event or Problem · 1

    A PATIENT HAD DIED FOLLOWING A LASER PROCEDURE WITH THE SLT II DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103794 CYNOSURE CELLULAZE - SLT II ND: YAG LASER OYW EL. EN. ELECTRONIC ENGINEERING SPA 08057017760009

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death