BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEO

    MDR report key: 23723084 · Received December 4, 2025

    Report

    Report Number
    2954354-2025-00009
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    August 8, 2025
    Report Date
    December 4, 2025
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    UDI-DI
    00816722021106
    PMA / PMN Number
    K023954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MW5175595 WAS SUBMITTED BY THE PATIENT WHO RECEIVED THE TREATMENT.

    Description of Event or Problem · 0

    INFORMATION FROM TREATING CLINIC ((B)(6) 2025): AFTER MULTIPLE REQUESTS FOR INFORMATION, DR. OLIVO'S OFFICE INFORMED CUTERA THAT THE PATIENT SUSTAINED A ~0.5-INCH BURN ON THE MIDLINE CHEST AND A ~1-INCH BURN ON THE GLUTEAL CLEFT. THE CLINIC REPORTED THAT THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. CUTERA WAS NOT NOTIFIED OF THESE INJURIES AT THE TIME OF OCCURRENCE IN (B)(6) 2025. CUTERA FIRST BECAUSE AWARE OF THE EVENT THROUGH THE MDR SUBMITTED DIRECTLY TO THE FDA BY THE PATIENT (MW5175595). FOLLOW-UP MEDICAL CARE (PER PATIENT REPORT): THE PATIENT STATED THAT SHE RECEIVED WOULD CARE AND SCAR MANAGEMENT AT A BURN CENTER UNDER THE CARE OF A PLASTIC SURGEON. REPORTED MANAGEMENT INCLUDED APPLICATION OF SILVER SULFADIAZINE CREAM TWICE DAILY, USE OF NON-STICK DRESSINGS, MONITORING FOR SIGNS OF INFECTION, AND ONGOING FOLLOW-UP FOR POTENTIAL HYPERTROPHIC OR KELOID SCARRING. ROOT CAUSE ASSESSMENT: THE DEVICE OPERATOR REPORTEDLY USED THE MAXIMUM RECOMMENDED FLUENCE (12 J/CM^2) IN COMBINATION WITH A REPETITION RATE ABOVE THE RECOMMENDED RANGE (10 HZ VERSUS THE RECOMMENDED 4-8 HZ). THIS COMBINATION LIKELY CONTRIBUTED TO EXCESSIVE THERMAL ACCUMULATION WITHIN THE SMALL TREATMENT AREA, RESULTING IN THERMAL INJURY. THE PATIENT DID NOT REPORT PAIN DURING TREATMENT, WHICH MAY HAVE REDUCED THE OPERATOR'S ABILITY TO DETECT EXCESSIVE HEATING. REPORTABILITY DETERMINATION: ALTHOUGH NO DEVICE MALFUNCTION OR PERFORMANCE ISSUE WAS IDENTIFIED, THE DEPTH, SIZE, AND LEVEL OF MEDICAL INTERVENTION REQUIRED FOR THE REPORTED BURNS MEET THE CRITERIA FOR MANDATORY REPORTING TO THE FDA. THIS EVENT IS CONSISTENT WITH KNOWN POTENTIAL ADVERSE EFFECTS DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE AND DOES NOT WARRANT CORRECTIVE OR PREVENTIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438685 XEO POWERED LASER SURGICAL INSTRUMENT GEX CUTERA, INC. 00816722021106

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other| R