BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 7020107 · Received November 10, 2017

    Report

    Report Number
    3006560326-2017-00020
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    PMA / PMN Number
    K161885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBERS OF THE DEVICES USED DURING TREATMENT WERE NOT PROVIDED BY THE PRACTICE; HOWEVER, A REVIEW OF PRODUCT RECORDS WAS UTILIZED TO IDENTIFY THE SERIAL NUMBER OF A MOTOR MODULE OWNED BY THIS PRACTICE. IT IS NOT CONFIRMED WHETHER THIS MOTOR MODULE WAS IN USE DURING THIS EVENT. AS THE PRACTICE DID NOT ALLEGE ANY MALFUNCTIONS OF A DEVICE, AND NO MALFUNCTIONS COULD BE IDENTIFIED WITH THE INFORMATION PROVIDED, THIS DEVICE WAS NOT REQUESTED BACK FOR EVALUATION. AN EVALUATION OF THE ORIGINAL DEVICE HISTORY RECORD FOUND THAT THERE HAVE BEEN NO DESIGN CHANGES ASSOCIATED WITH THE MOTOR MODULE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT IS NOT CONFIRMED WHETHER A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT EVENT. NO FURTHER INFORMATION REGARDING THE PATIENT HAS BEEN PROVIDED. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE ON TEN OCCASSIONS; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE TREATING PRACTICE EMAILED MERZ DEVICE INNOVATION CENTER ON 30-MAR-2018 STATING THAT THE PATIENT HAS HEALED AFTER 5 MONTHS. THE PRACTICE ALSO STATED THAT THE PATIENT "WILL NEED SCAR REVISION PROBABLY LASER RESURFACING" AND POSTCARE WAS A GARMENT ATC, NO EXERCISE FOR 2 WEEKS, AND "ARNICA AND BROMELIAN". WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH FROM WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO GATHER TREATMENT/MEDICAL RECORDS AND A TREATMENT STRATEGY MAP FROM THE HEALTHCARE PROVIDER WERE MADE ON THE FOLLOWING DATES: (B)(6) 2017. WHEN ADDITIONAL INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A MERZ FIELD REPRESENTATIVE WAS MADE AWARE ON 11-OCT-2017 OF AN ADVERSE EVENT THAT OCCURRED FOLLOWING A CELLFINA TREATMENT. THE PRACTICE STATES THAT THE TREATMENT OCCURRED ON (B)(6) 2017 ON THE LATERAL THIGH AREA, AND THE FOLLOWING MORNING, THE PATIENT AWOKE WITH BLISTERS. THE PATIENT HAS REACHED OUT TO ULTHERA, INC., MERZ DEVICE INNOVATION CENTER TO REPORT THAT SHE HAD A "MAJOR REACTION" TO HER CELLFINA TREATMENT AND IS EXPERIENCING "THIRD DEGREE BURNS" AND "TWO GIANT ULCERS...THAT WILL SCAR AND REQUIRE SURGERY." THE PATIENT ALSO REPORTED THAT SHE HAD TO TAKE ORAL ANTIBIOTICS AND APPLY OINTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798762 THE CELLFINA SYSTEM THE CELLFINA SYSTEM OUP ULTHERA, INC., MERZ DEVICE INNOVATION CENTER CM-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other