BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA SYSTEM

    MDR report key: 7505224 · Received May 10, 2018

    Report

    Report Number
    3006560326-2018-00004
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 12, 2018
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OHV
    UDI-DI
    00840763100247
    PMA / PMN Number
    K134032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICES USED DURING TREATMENT WERE NOT PROVIDED BY THE PRACTICE. ADDITIONALLY, ATTEMPTS TO OBTAIN THE LOCATION OF THE DENTAL OFFICE THAT PERFORMED THE DENTAL IMPLANT REMOVAL FOR ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. A SUPPORT LOG WAS PROVIDED BY THE PRACTICE, AND DURING EVALUATION NO MALFUNCTIONS WERE OBSERVED DURING TREATMENT NOR WERE DEVIATIONS FROM TREATMENT PROTOCOL LISTED IN THE INSTRUCTIONS FOR USE WERE IDENTIFIED. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON THE ULTHERA CONTROL UNIT, HANDPIECE, AND TRANSDUCERS USED DURING TREATMENT. A REVIEW OF THE DHR RECORDS FOR THE CONTROL UNIT AND HANDPIECE IDENTIFIED THERE WERE TWO UNRELATED DEVIATIONS THAT WOULD NOT HAVE IMPACTED THE EVENT ASSOCIATED WITH THE MANUFACTURE OF THESE DEVICES. NO NON-CONFORMANCES WERE IDENTIFIED AND BOTH DEVICES PASSED ALL REQUIRED TESTING PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR RECORDS FOR THE TWO TRANSDUCERS USED DURING TREATMENT DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURE OF THESE DEVICES, AND BOTH DEVICES PASSED ALL REQUIRED TESTING PRIOR TO DISTRIBUTION. A REVIEW OF THE SERVICE HISTORY RECORDS FOR BOTH THE CONTROL UNIT AND THE HANDPIECE SHOW THAT NEITHER DEVICE HAS BEEN RETURNED FOR SERVICE SINCE DISTRIBUTION. A REVIEW OF THE PATIENT COMPLAINT TREND ANALYSIS REVEALED THE REPORTED ISSUES OF "EDEMA" AND "BRUISE" FOUND A TREND HAS NOT BEEN IDENTIFIED AND WILL CONTINUE TO BE MONITORED. A REVIEW OF THE PATIENT COMPLAINT TREND ANALYSIS REVEALED THE REPORTED ISSUE OF "PAIN" HAS SIGNALED A TREND AND A CAPA HAS BEEN OPENED TO INVESTIGATE THE ISSUE. INVESTIGATION OF THIS REPORT FOUND THAT THE MERZ/ULTHERA DEVICES DID NOT MALFUNCTION AS THE PRACTICE STATED THE DEVICES PERFORMED AS INTENDED AND NO MALFUNCTIONS COULD BE IDENTIFIED DURING EVALUATION OF THE SUPPORT LOG. INVESTIGATION WAS UNABLE TO CONFIRM IF A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 12-APR-2018, ULTHERA, INC., MERZ DEVICE INNOVATION CENTER BECAME AWARE VIA EMAIL OF A PATIENT WHO REPORTED DEVELOPING SWELLING AROUND A MENTAL DENTAL IMPLANT FOLLOWING AN ULTHERAPY TREATMENT. THE TREATMENT DATE WAS REPORTED AS (B)(6) 2018 AND THE PATIENT REPORTED THE EVENT TO THEIR TREATING PRACTICE ON (B)(6) 2018. THE PATIENT'S INITIAL REPORT STATED THEY EXPERIENCED WARMTH AROUND THE DENTAL IMPLANT DURING THE TREATMENT, AND THAT TWO DAYS FOLLOWING THE TREATMENT THEY EXPERIENCED FACIAL SWELLING "AND VERY PAINFUL ON DENTAL IMPLANT SIDE." SOMETIME BETWEEN (B)(6) 2018, THE PATIENT WAS PRESCRIBED ANTIBIOTICS PROACTIVELY, AND HAD THE DENTAL IMPLANT REMOVED BY THEIR DENTIST.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED BY THE TREATING PRACTICE, NO ISSUES WITH THE DEVICE OCCURRED DURING USE. DURING THE TREATMENT THE PATIENT REPORTED FEELING WARMTH IN THE AREA OF THEIR DENTAL IMPLANT WHILE A BLUE TRANSDUCER (PER REVIEW OF THE SYSTEM SUPPORT LOG PART NUMBER UT-2, SERIAL NUMBER (B)(4)) WAS IN USE. THE TREATING PRACTICE INDICATED THEY SWITCHED TO A DIFFERENT TRANSDUCER TYPE, AFTER WHICH THE PATIENT REPORTED NO FURTHER WARMTH. THE TREATING PRACTICE STATED THE PATIENT'S SWELLING HAD BEEN REDUCED FOLLOWING THE REMOVAL OF THE DENTAL IMPLANT, BUT THAT THE PATIENT WAS NOW EXPERIENCING BRUISING AND TENDERNESS. ATTEMPTS TO DETERMINE THE CONTACT INFORMATION FOR THE PATIENT'S DENTIST WERE PERFORMED ON (B)(6) 2018; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE TRANSDUCER IN USE AT THE TIME OF THE REPORT HAS BEEN REQUESTED TO BE RETURNED AND A FOLLOW-UP REPORT WILL BE SUBMITTED AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(4) 2018, ULTHERA, INC.,(B)(4) DEVICE INNOVATION CENTER BECAME AWARE VIA EMAIL OF A PATIENT WHO REPORTED DEVELOPING SWELLING AROUND A MENTAL DENTAL IMPLANT FOLLOWING AN ULTHERAPY TREATMENT. THE TREATMENT DATE WAS REPORTED AS (B)(6) 2018 AND THE PATIENT REPORTED THE EVENT TO THEIR TREATING PRACTICE ON (B)(6) 2018. THE PATIENT'S INITIAL REPORT STATED THEY EXPERIENCED WARMTH AROUND THE DENTAL IMPLANT DURING THE TREATMENT, AND THAT TWO DAYS FOLLOWING THE TREATMENT THEY EXPERIENCED FACIAL SWELLING "AND VERY PAINFUL ON DENTAL IMPLANT SIDE." SOME TIME BETWEEN (B)(6) 2018, THE PATIENT WAS PRESCRIBED ANTIBIOTICS PROACTIVELY, AND HAD THE DENTAL IMPLANT REMOVED BY THEIR DENTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346750 ULTHERA SYSTEM ULTHERA SYSTEM OHV ULTHERA, INC., MERZ DEVICE INNOVATION CENTER UC-1 00840763100247

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other IBUPROFEN