BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA SYSTEM

    MDR report key: 20592305 · Received November 1, 2024

    Report

    Report Number
    3006560326-2024-00008
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 5, 2024
    Report Date
    November 1, 2024
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    UDI-DI
    00840763100902
    PMA / PMN Number
    K180623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO MALFUNCTIONS OF AN ULTHERA DEVICE DURING TREATMENT WERE ALLEGED RELATED TO THIS REPORTED EVENT. ATTEMPTS TO OBTAIN A SUPPORT LOG AND ADDITIONAL INFORMATION RELATED TO THE DEVICES USED DURING THIS TREATMENT WERE MADE ON 11-OCT-2024, 16-OCT-2024, 21-OCT-2024, 25-OCT-2024, AND 29-OCT-2024. NO ADDITIONAL INFORMATION WAS PROVIDED. FOUR DEVICES WERE REPORTED TO HAVE BEEN USED DURING TREATMENT: ULTHERA UC-1 CONTROL UNIT (SERIAL NUMBER: (B)(6)), UH-2 HANDPIECE (SERIAL NUMBER: (B)(6)), AND TRANSDUCERS (SERIAL NUMBERS: (B)(6)). AN EVALUATION OF THE ORIGINAL DEVICE HISTORY RECORDS (DHRS) FOR ULTHERA UC-1 CONTROL UNIT (SERIAL NUMBER: (B)(6)) AND UH-2 HANDPIECE (SERIAL NUMBER: (B)(6)) REVEALED NO DEVIATIONS, REWORK, OR NON-CONFORMANCES WERE ASSOCIATED WITH THE MANUFACTURE OF THESE DEVICES. ALL REQUIRED TESTING PASSED PRIOR TO DISTRIBUTION FOR EACH DEVICE. A REVIEW OF SERVICE HISTORY RECORDS (SHRS) FOR THE CONTROL UNIT AND HANDPIECE FOUND NEITHER DEVICE HAS BEEN SERVICED SINCE DISTRIBUTION. AN EVALUATION OF THE DHRS FOR THE REPORTED TRANSDUCERS COULD NOT BE PERFORMED AS THEY ARE NOT KNOWN ULTHERA DEVICE SERIAL NUMBERS. ATTEMPTS TO OBTAIN CLARIFICATION OF THE ULTHERA TRANSDUCER SERIAL NUMBERS WERE NOT SUCCESSFUL. THE PATIENT INVESTIGATION FOUND THERE ARE NOT ENOUGH DETAILS TO CONFIRM WHETHER A MERZ/ULTHERA DEVICE MALFUNCTIONED DURING TREATMENT. AS THE SERIAL NUMBERS PROVIDED FOR THE TRANSDUCERS USED DURING THIS TREATMENT ARE NOT KNOWN ULTHERA SERIAL NUMBERS, IT IS UNKNOWN IF THE TRANSDUCER SERIAL NUMBERS WERE INCORRECTLY PROVIDED OR IF THE TRANSDUCERS USED WERE NOT AUTHENTIC ULTHERA DEVICES. IT IS UNCONFIRMED WHETHER A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE ALLEGED PATIENT INJURY. REPORTEDLY, THE BURN WAS ASSESSED TO BE A THIRD-DEGREE BURN. NO INFORMATION ON CORRECTIVE TREATMENT WAS PROVIDED. ADDITIONALLY, THE INFORMATION IN THIS CASE IS QUITE SPARSE AND NO FURTHER INFORMATION ON EVENT DETAILS OR UNDERLYING CONDITIONS WERE PROVIDED. CAUSALITY IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH ULTHERA SYSTEM DUE TO COMPATIBLE LOCAL AND TEMPORAL RELATIONSHIP. THIS CASE IS CONSERVATIVELY CONSIDERED AS SERIOUS WITH THE SERIOUS EVENT APPLICATION SITE BURN BECAUSE POTENTIAL MEDICAL INTERVENTION IS DEEMED NECESSARY TO PREVENT A PERMANENT DAMAGE. NO ADDITIONAL INVESTIGATION OR CORRECTIVE ACTIONS ARE WARRANTED FOR THIS COMPLAINT. FURTHERMORE, THIS COMPLAINT IS NOT SUBJECT TO ANY CURRENT FIELD CORRECTIVE ACTION (FCA). ULTHERA WILL MONITOR COMPLAINT DATA ACCORDING TO CURRENT STATISTICAL TREND ANALYSIS PROCEDURES. ANY STATISTICALLY VALID SIGNALS OR TRENDS WILL BE ESCALATED TO MRB VIA ISSUE REVIEW FOR CAPA CONSIDERATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 11-OCT-2024, ULTHERA RECEIVED INFORMATION FROM A BRAZILIAN AFFILIATE VIA EMAIL REGARDING A POTENTIAL ULTHERA ADVERSE EVENT. ACCORDING TO THE REPORT, ULTHERAPY WAS PERFORMED ON A MALE PATIENT, DEMOGRAPHICS UNKNOWN, TO THE MIDDLE THIRD OF THE FACE ON (B)(6) 2024. THE FOLLOWING DAY, (B)(6) 2024, THE PATIENT ALLEGEDLY EXPERIENCED A ¿GRADE 3¿ BURN ON THE LOWER THIRD OF THE LEFT SIDE OF THE FACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PATIENT¿S TREATMENT AND PATIENT SYMPTOM RESOLUTION WERE MADE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630833 ULTHERA SYSTEM FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION OHV MERZ NORTH AMERICA, INC. UC-1 00840763100902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention