BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLIPO MPX

    MDR report key: 3850602 · Received May 22, 2014

    Report

    Report Number
    1222993-2014-00016
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 22, 2014
    Product Code
    GEX
    PMA / PMN Number
    K062321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER SYSTEM IS NOT A SINGE USE DEVICE. PHYSICIAN USED A SINGLE FIBER MULTIPLE TIMES AND THE PT IS INJURED.

    Description of Event or Problem · 1

    PHYSICIAN TREATING CUSTOMER TO REMOVE FAT FROM NECK AND CHIN AREA. PHYSICIAN USED A SINGLE USE FIBER MULTIPLE TIMES AND PT PRESENT WITH A BURN AND IS PRESCRIBED SILVANDENE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306587 SMARTLIPO MPX GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention