BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM LASER/IPL

    MDR report key: 7488212 · Received May 4, 2018

    Report

    Report Number
    3011593504-2018-00001
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    April 6, 2018
    Report Date
    April 17, 2018
    Manufacturer
    ROHRER AESTHETICS, LLC
    Product Code
    GEX
    UDI-DI
    0100860564000317
    PMA / PMN Number
    K123777
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, OUR CUSTOMER, PINNACLE PLASTIC SURGERY CALLED OUR OWNER MARK ROHRER TO LET HIM KNOW THAT A PATIENT MIGHT HAVE A SCAR AFTER BEING TREATED BY THE LONG PULSE YAG HANDPIECE ON THE SPECTRUM/IPL LASER. OUR SERVICE MANAGER WAS NOTIFIED AND A APPOINTMENT WAS SCHEDULED FOR MONDAY (B)(6) 2019 TO INVESTIGATE THE DEVICE. THE PATIENT WILL BE MONITORED OVER THE NEXT SEVERAL WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329323 SPECTRUM LASER/IPL MULTI-PLATFORM LASER/IPL GEX ROHRER AESTHETICS, LLC 0100860564000317

    Patients

    Seq Age Sex Outcome Treatment
    1