BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 10025824 · Received May 5, 2020

    Report

    Report Number
    3006560326-2020-00004
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Report Date
    April 6, 2020
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    PMA / PMN Number
    K192185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REPORTED TO BE DISPOSED OF BY THE TREATMENT PROVIDER AND THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. A REVIEW OF THE CELLFINA PRODUCT COMPLAINT TRENDING ANALYSIS OF "BLADE BREAKS" REVEALED THAT NOT ENOUGH COMPLAINTS HAVE BEEN RECEIVED FOR THIS REPORTED ISSUE TO GENERATE A TREND. A REVIEW OF THE CELLFINA PRODUCT COMPLAINT TRENDING ANALYSIS OF "BLADE DIFFICULTY CUTTING" REVEALED THAT NOT ENOUGH COMPLAINTS HAVE BEEN RECEIVED FOR THIS REPORTED ISSUE TO GENERATE A TREND. A REVIEW OF THE LOT COMPLAINT HISTORY AND LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE REPORTED CELLFINA DISPOSABLE KIT WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE TREATMENT PROVIDER REPORTED THAT THE CELLFINA DISPOSABLE KIT USED DURING THIS TREATMENT WAS DISPOSED OF AND THE LOT NUMBER OF THE DEVICE WAS NOT DOCUMENTED. THEREFORE, THE REPORTED CELLFINA DISPOSABLE KIT COULD NOT BE REQUESTED FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO BE NOT AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO A MERZ PRACTICE DEVELOPMENT SPECIALIST ON (B)(6) 2020 INFORMATION REGARDING A CELLFINA SYSTEM DEVICE MALFUNCTION. THE REPORTER ALLEGED THAT THE BLADE OF A CELLFINA DISPOSABLE KIT WAS NOT CUTTING WELL DURING THE FIRST TWO RELEASES OF A TREATMENT; DURING POSITIONING TO START THE THIRD DEPRESSION, THE BLADE BROKE. THE REPORTER ALLEGED THAT NO PATIENT INJURY OCCURED IN CONJUNCTION WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489657 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP ULTHERA, INC., MERZ DEVICE INNOVATION CENTER CK1-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other