BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 24372925 · Received February 17, 2026

    Report

    Report Number
    3031944951-2026-00002
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    December 18, 2025
    Report Date
    February 17, 2026
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    UDI-DI
    00086056400031
    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

    DEVICE TESTED WITHIN SPECIFICATIONS. USER FACILITY WAS EDUCATED ON SKIN TYPING AND PROPER TREATMENT PROTOCOLS.

    Description of Event or Problem · 0

    PATIENT PRESENTED ON (B)(6) 2025 FOR CONSULTATION FOR SPIDER VEINS ON BOTH OF HER LOWER EXTREMITIES. PATIENT HAS HAD SPIDER VEINS SINCE BEING A TEEN. SHE HAS DONE SCLEROTHERAPY TOW TIMES WITH BENEFIT THE FIRST TIME (BEFORE COVID) AND NOT MUCH NOTICEABLE BENEFIT THE SECOND TREATMENT (WITH A DIFFERENT DOCTOR. FIRST TREATMENT WITH A VEIN SPECIALISTS AND PLASTIC SURGEON AND SECOND TREATMENT WITH A DERMATOLOGIST.) SHE HAS DONE V BEAM AND VASCULYZE LASER WITHOUT BENEFIT AT OTHER LOCATIONS. SHE WAS REFERRED BY A FRIEND AND PRESENTED FOR CONSULTATION FOR TREATMENT. AFTER CONSULTATION, DECIDED TO DO A TEST PATCH IN A SMALL AREA TO SEE IF WOULD NOTICE THE EXPECTED FADING OF THE VEIN. DID TEST PATCH AND NOTED IMPROVEMENT. PATIENT DESIRED TO CONTINUE WITH TREATMENT IF TIME ALLOWED TO AVOID DRIVING AGAIN. APPOINTMENTS FOR VEIN TREATMENTS ARE SCHEDULED IN 15 MINUTE INCREMENTS. NOT ALL THE VEINS WERE COMPLETED IN THE FIRST 15 MINUTE INCREMENT, PATIENT ASKED IF SHE COULD COMPLETE THE TREATMENT AS SHE PREFERRED IT ALL IN ONE TREATMENT. EXPLAINED THAT SOME VEINS ARE DEEPER AND NOT AMENABLE TO LASER AND DIDN'T TREAT THOSE VEINS. PATIENT STATED SHE UNDERSTOOD. NO VOICED CONCERNS DURING THE TREATMENT. THE AREAS APPEARED TO FADE AS EXPECTED DURING TREATMENT. SINGLE PULSE, NO OVERLAP DONE, AREAS TREATED ONCE. BY THE TIME THE APPOINTMENT WAS DONE, THERE WAS MILD TO MODERATE ERYTHEMA/SWELLING ALONG TREATED AREAS. NO BLISTERS NOTED. BACITRACIN APPLIED. ADVISED SHE CAN ICE THE AREAS. AVOID SAUNAS, HOT SHOWERS, EXERCISE. THAT EVENING THE PATIENT CALLED AND LEFT A VOICEMAIL WHICH WAS HEARD THE NEXT MORNING. SHE ALSO TEXTED THE NEXT MORNING WITH CONCERN ABOUT BLISTERING AND QUESTIONS POTENTIAL BURN AND NEEDED TO BE SEEN AS SOON AS POSSIBLE. SHE SENT PHOTOS. REACHED OUT IN THE MORNING AND SCHEDULED A FOLLOW UP. ON (B)(6) 2025 AREAS EXAMINED, PHOTOS OBTAINED. PERI-CENTIMETER BLISTERS NOTED ALONG THE LATERAL ASPECT OF PATIENTS RIGHT KNEE AT THE SITE OF A CLUSTERED SPIDER VEINS AND UNDERLYING MORE PROMINENT VEIN. MAJORITY OF AREAS APPEAR SLIGHTLY DARKER, ERYTHEMATOUS AND SLIGHTLY RAISED. OVERALL, THE DEGREE OF SWELLING AND ERYTHEMA IS LESS THAN POST TREATMENT. NO ASYMMETRIC SWELLING OF THE LOWER EXTREMITIES OR CONCUR FOR DVT. NO FEVERS. AREAS LOOKED WITHIN THE RANGE OF EXPECTED POST TREATMENT. THE SWELLING HAD ESSENTIALLY RESOLVED AND IT LOOKED LIKE THE CAT SCRATCH REACTION FOR THE MOST PART, EXCEPT FOR THE TWO VESICULAR AREAS ALONG THE RIGHT LATERAL KNEE. THE AREAS WERE CLEANED. OXYGEN THERAPY USED ON ALL THE AREAS AND COOLING TREATMENT DONE WITH THE TARGET COOL DEVICE TO HELP DECREASE INFLAMMATION AND PROMOTE HEALING. BACITRACIN APPLIED ON ALL AREAS AND NONADHESIVE GAUZE WITH PAPER TAPE PLACED ON THE MORE PROMINENT AREAS. ADVISED PATIENT TO KEEP THE AREAS CLEAN, MINIMIZE ANY FRICTION ON THE AREAS AND TO CONTINUE TO APPLY THE BACITRACIN AND NONADHESIVE GAUZE. GAVE THE PATIENT SUPPLIES (NONADHESIVE GAUZE, PAPER TAPE, BACITRACIN). PATIENT CONCERNED ABOUT PIGMENTATION/PIH. SHE STATES SHE HAS A HISTORY OF SIGNIFICANT PIH WITH NEARLY EVERYTHING, HER SKIN IS MORE REACTIVE. PATIENT ASKED IF THERE IS PIGMENTATION ISSUES IF SHE COULD BE TREATED AT NO COST FOR THE AREAS. ADVISED HER TO CONTINUE WITH TIME AND PROTOCOL TO SEE HOW EVERYTHING WILL HEAL AND WILL ADDRESS AS NEEDED. FOLLOW UP SCHEDULED IN 2.5 WEEKS. ON (B)(6) 2025 PATIENT REACHED OUT TO SAY IT IS OPEN FLESH AND SENT A PHOTO. IT LOOKED LIKE ONE OF THE VESICLES UNROOFED. ADVISED TO CONTINUE WITH WOUND CARE AS DIRECTED AND KEEP IT CLEAN. ON 12/24/2025 FACILITY REACHED OUT TO PATIENT VIA TEXT AND SHE STATED SHE IS STRESSED AND STILL AN OPEN WOUND. ON (B)(6) 2026 PATIENT CAME IN FOR FOLLOW UP. PATIENT STATED THAT SHE HAS BEEN EXTREMELY STRESSED AND NOT DOING WELL. SHE STATED THAT ON 12/26/2025 SHE REACHED OUT TO HER INITIAL PHYSICIAN THAT DID THE SCLEROTHERAPY AND SAW THEM (B)(6) 2025. THAT DOCTOR SAID HE WOULD NEVER HAVE TREATED HER (FITZ IV) WITH THE LONG PULSE YAG AND HE DIAGNOSED AS BURNS. PREVIOUS DOCTOR STATED THAT 10 DAYS OF HEALING HAVE BEEN LOST. HE TREATED HER WITH A LAMB SKIN GRAFT AND WOUND CARE FOR THE OPEN WOUND AND ADVISED HER TO USE CREAMS TO HELP WITH THE PIGMENTATION AND STEROID INJECTIONS INTO THE WOUND TO DELAY HEALING/HELP AVOID SCARRING. PATIENT STATES THAT THE OTHER DOCTOR IS FAIRLY OPTIMISTIC TO BE ABLE TO HELP HER WITH THE WOUND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432019 SPECTRUM POWERED LASER SURGICAL INSTRUMENT GEX ROHRER AESTHETICS, INC. SPECTRUM 00086056400031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention