BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT II CELLULAZE

    MDR report key: 4660173 · Received April 3, 2015

    Report

    Report Number
    1222993-2015-00010
    Event Type
    Injury
    Date Received
    April 3, 2015
    Date of Event
    March 4, 2015
    Report Date
    April 2, 2015
    Product Code
    OYW
    PMA / PMN Number
    K102541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED HAVING LIPOLYSIS TREATMENT 2 YEARS AGO (2013) USING THE CELLULAZE DEVICE. PATIENT EXPERIENCED BLUE, BRUISING PIGMENTATION AND DROOPED BUTTOCKS. CYNOSURE BECAME AWARE ON (B)(6) 2015 AND ASSESSED THE PATIENT INCIDENT/LASER DEVICE USED. THE LASER WAS FOUND TO BE OPERATIONAL AND WORKING WITHIN ESTABLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT HAD TREATMENT FOR LIPOLYSIS 2 YEARS AGO (2013), BUT DID NOT SUBMIT A COMPLAINT TO CYNOSURE UNTIL (B)(6) 2015. THE EVENT INVOLVED THE PATIENT HAVING BLUE, BRUISED PIGMENTATION AND DROPPED BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221364 SLT II CELLULAZE LASER OYW CELLULAZE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability