{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-20", "results": { "skip": 0, "limit": 1, "total": 219 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3006560326-2020-00005", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "K134032", "date_of_event": "20180523", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "IS", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "605766", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200611", "brand_name": "ULTHERA SYSTEM", "generic_name": "ULTHERA SYSTEM", "manufacturer_d_name": "ULTHERA, INC., MERZ DEVICE INNOVATION CENTER", "manufacturer_d_address_1": "1840 SOUTH STAPLEY DRIVE", "manufacturer_d_address_2": "SUITE 200", "manufacturer_d_city": "MESA, AZ", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "UC-1", "catalog_number": "UC-1", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OHV", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4590", "device_class": "2" } } ], "product_problems": [ "Off-Label Use", "Off-Label Use" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Edema", "Nerve Damage", "Neuropathy", "Pain", "Tissue Damage", "Edema", "Nerve Damage", "Neuropathy", "Pain", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20200304", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145766", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319051328", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "UNSUCCESSFUL ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT, TREATMENT DETAILS, AND DEVICE SERIAL NUMBER INFORMATION WERE PERFORMED ON (B)(6)2020, (B)(6) 2020, AND (B)(6)2020. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME." }, { "mdr_text_key": "319051329", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT, TREATMENT DETAILS, AND DEVICE SERIAL NUMBER INFORMATION WERE PERFORMED ON (B)(6)2020, (B)(6)2020, AND (B)(6)2020. THE ATTEMPTS WERE UNSUCCESSFUL AS THERE WAS NO RESPONSE FROM THE REPORTER. AS A RESULT, AN INVESTIGATION OF THE ACTUAL DEVICE AND REVIEWS OF THE ULTHERA® SYSTEM DEVICE HISTORY RECORD AND SERVICE HISTORY RECORD WERE UNABLE TO BE PERFORMED. A REVIEW OF THE ULTHERA® SYSTEM INSTRUCTIONS FOR USE (IFU) WAS PERFORMED, AND REVEALED THE REGION OF THE MID-FOREHEAD IS NOT LISTED IN IN THE \"INDICATIONS FOR USE\" SECTION AND THE MID-FOREHEAD REGION IS AN AREA THAT SHOULD NOT BE TREATED WITH ULTHERAPY. THE USE OF THE ULTHERA® SYSTEM ON THE REPORTED REGION OF THE FOREHEAD MOST LIKELY CONTRIBUTED TO THE EVENT. A REVIEW OF THE CURRENT ULTHERAPY PATIENT COMPLAINT TRENDING ANALYSIS REPORT FOR THE REPORTED ISSUES OF \"TENDERNESS/SORENESS/PAIN/SENSITIVITY TO TOUCH\" AND \"EDEMA\" REVEALED A TREND WAS IDENTIFIED FOR BOTH CONDITIONS AND AN INVESTIGATION HAVE BEEN OPENED. A REVIEW OF THE CURRENT ULTHERAPY PATIENT COMPLAINT TRENDING ANALYSIS REPORT FOR THE REPORTED ISSUES OF \"NEUROPATHY/PARESTHESIA\" AND \"PATIENT OTHER\" REVEALED THAT THE TREND LEVELS ARE WITHIN ALLOWABLE LIMITS AND WILL CONTINUE TO BE MONITORED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "200856552", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE (B)(6) DISTRIBUTION PARTNER BECAME AWARE OF THIS REPORT ON (B)(6) 2020 AND DID NOT NOTIFY MERZ/ULTHERA UNTIL (B)(6) 2020. A SCAR HAS BEEN ISSUED TO INVESTIGATE AND ADDRESS THE LATE REPORT. BASED ON THE INFORMATION RECEIVED THUS FAR, NO MALFUNCTIONS OF AN ULTHERAPY DEVICE WERE ALLEGED. ACCORDING TO THE REPORT, A PHYSICIAN WAS PERSONALLY TREATED WITH ULTHERAPY AND KNOWINGLY RECEIVED TREATMENT ON THE FOREHEAD WHICH IS AN OFF-LABEL AREA PER THE ULTHERA SYSTEM INSTRUCTIONS FOR USE. UNSUCCESSFUL ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE TREATMENT, EVENT, AND DEVICE SPECIFICS WERE PERFORMED ON 14-MAY-2020 AND 26-MAY-2020. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "200856633", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A MERZ/ULTHERA AFFILIATE RECEIVED A REPORT FROM AN (B)(6) BASED DISTRIBUTION PARTNER ON (B)(6) 2020 REGARDING A PHYSICIAN THAT UNDERWENT ULTHERAPY TREATMENT ALLEGING AN ADVERSE EVENT. ACCORDING TO THE REPORT, THE PHYSICIAN/PATIENT STATED \"DURING ONE OF MR. [...] TRAINING VISITS TO (B)(6), ON (B)(6) 2018, I WAS THE \"MODELING PATIENT\" WHEN HE PERFORMED A SKIN TEXTURE TREATMENT ON MY FULL FACE, INCLUDING UPPER THIRD, NAMELY FOREHEAD. THE TREATMENT WAS DOCUMENTED ON FILM, AS WELL AS MY \"BEFORE & AFTER\" PHOTOS, FOR PROTOCOL AND TRAINING PURPOSES. THE TREATMENT WAS UNEVENTFUL EXCEPT MODERATELY PAINFUL. FOLLOWING THE TREATMENT I SUFFERED SEVERE EDEMA FOR 10 DAYS AND MODERATE TO LIGHT EDEMA FOR ADDITIONAL 10 DAYS. THE PROCESS WAS OF COURSE PAINFUL BUT TOLERABLE. AFTER APPROXIMATELY 10 DAYS, WHEN THE PROCESS STARTED CALMING DOWN, I SPOTTED A VERY HYPERESTHETIC AREA IN MID FOREHEAD, PAINFUL AND ELECTRICAL CURRENT LIKE WHEN TOUCHED. UNFORTUNATELY THE ABOVE DESCRIBED SYMPTOMS DID NOT RESOLVE, THEY MAINTAIN UNTIL NOW. MOREOVER, AFTER A COUPLE OF WEEKS A GROOVE APPEARED, VERTICALLY DIVIDING MY FOREHEAD INTO TWO HALVES AND LOOKING AS A DARK SHADOW. IT IS, BY APPEARANCE AND MECHANISM OF ACTION, LIKELY TO BE AN ABLATED SUPERFICIAL VEIN, ADHESSED FROM BELOW TO THE FRONTAL BONE AND TO THE SKIN FROM ABOVE. THE PHENOMENON IS STABLE AND HAS NOT CHANGED FOR OVER A YEAR AND A HALF. THE GROOVE SHADOW LIKE APPEARANCE IS AN AESTHETIC DEFECT, WHILE THE CONSTANT TENDERNESS WORSENED BY ANY CONTACT, SUCH AS A HAIR COMB, IS HIGHLY ANNOYING. ALTHOUGH HAVING VAST EXPERIENCE IN GENERAL AND VASCULAR SURGERY, I ADVISED COLLEAGUES FROM THE FIELD OF PHLEBOLOGY AS WELL AS PLASTIC SURGERY. THEY ALL AGREE THE PATHOPHYSIOLOGY OF THE ABOVE DESCRIBED PHENOMENON IS IRREVERSIBLE VEIN AND NERVE DAMAGE, BY MECHANISM OF THERMAL ABLATION. DURING A SKIN TEXTURE TREATMENT USING ULTRASOUND THE TEMPERATURES CAN GET EXTREMELY HIGH, AS THE HEAT IS ACCUMULATED, WHILE THE SPECIFIC CASE OF FOREHEAD IS EVEN MORE EXTREME DUE TO THE UNDERLYING FRONTAL BONE. THE BONE PLAYS AN IMPORTANT ROLE IN ACCUMULATING HEAT, RISING DOUBTS CONCERNING THIS SPECIFIC PROTOCOL SAFETY. THE FACT FOREHEAD SKIN TEXTURE TREATMENT IS AN OFF LABEL PROTOCOL IS RATHER DISTURBING AS ITS' SAFETY WAS NOT ESTABLISHED FULLY AND LITTLE DO WE KNOW ABOUT SUCH SPECIFIC ISSUES. FOLLOWING MY CASE I STOPPED CARRYING OUT ANY OFF LABEL PROTOCOLS AND I AM EXTREMELY CAREFUL WITH THE UPPER THIRD.\" NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/10/2020" } ] }