BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 22036786 · Received May 16, 2025

    Report

    Report Number
    3031944951-2025-00003
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    February 26, 2025
    Report Date
    July 1, 2025
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    UDI-DI
    00860564000317
    PMA / PMN Number
    K123777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS USED SEVERAL TIMES A WEEK ON PATIENTS AND THERE WAS NO MALFUNCTION OF THE DEVICE. WE WILL CONTINUE TO MONITOR THE HEALTH OF THE PATIENT.

    Additional Manufacturer Narrative · 0

    THE HEALTH OF THE PATIENT HAS IMPROVED ON LAST CONTACT. DEVICE HAS BEEN IN USE CONTINUALLY WITH NO OTHER ADVERSE EVENTS. USER FACILITY AND ROHRER AESTHETICS HAVE AGREED THAT THIS CASE CAN BE CLOSED.

    Description of Event or Problem · 0

    CUSTOMER OF ROHRER AESTHETICS, TT AESTHETICS, REPORTED THAT A MALE HAD 3 TATTOO REMOVAL TREATMENTS FOR GANG RELATED TATTOO'S, ((B)(6) 2024, (B)(6) 2025, USING THE SPECTRUM Q-SWITCH DEVICE. HE WAS SCHEDULED TO COME IN FOR A 4TH TREATMENT ON (B)(6) 2025. IT WAS AT THIS TIME HE CANCELLED HIS APPOINTMENT BECAUSE HEALING HAS BEEN SLOWER AND HE WASN'T READY FOR THE NEXT TREATMENT. HE THEN NOTIFIED THEM THAT HE WENT TO THE EMERGENCY ROOM FOR TREATMENT AND WAS DIAGNOSED WITH 3RD DEGREE BURNS.

    Description of Event or Problem · 0

    FOLLOW UP AND CLOSE ORIGINAL REPORT 3031944951-2025-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833392 SPECTRUM POWERED LASER SURGICAL INSTRUMENT GEX ROHRER AESTHETICS, INC. SPECTRUM 00860564000317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention