BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 11791568 · Received May 7, 2021

    Report

    Report Number
    3013840437-2021-00121
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OUP
    PMA / PMN Number
    K192185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRACTICE REPORTED THE CELLFINA DISPOSABLE KIT USED DURING THIS TREATMENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR EVALUATION. ATTEMPTS TO OBTAIN THE LOT NUMBER OF THE CELLFINA DISPOSABLE KIT USED DURING THIS TREATMENT AND OTHER PERTINENT INFORMATION REGARDING THE EVENT FROM THE PRACTICE WERE MADE ON 09-APR-2021, 13-APR-2021, 28-APR-2021, AND 06-MAY-2021. THE PRACTICE DID NOT PROVIDE ANY ADDITIONAL INFORMATION. A SEARCH OF THE MERZ EQUIPMENT MASTER IDENTIFIED CELLFINA SYSTEM MOTOR MODULE (SERIAL NUMBER C(B)(4)) WAS THE ONLY MOTOR MODULE OWNED BY THE PRACTICE. ALTHOUGH IT CANNOT BE CONFIRMED THIS DEVICE WAS USED DURING TREATMENT, IT HAS BEEN INCLUDED IN THIS INVESTIGATION. AN EVALUATION OF THE SERVICE HISTORY OF THE CELLFINA SYSTEM MOTOR MODULE WAS NOT PERFORMED AS CELLFINA DEVICES ARE NOT SERVICEABLE EQUIPMENT. AN EVALUATION OF THE LOT COMPLAINT HISTORY FOR THE CELLFINA DISPOSABLE KIT ASSOCIATED WITH THIS EVENT WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE CELLFINA SYSTEM MOTOR MODULE IDENTIFIED ONE DEVIATION WAS RELATED TO THE MANUFACTURE OF THIS DEVICE; HOWEVER, THIS ISSUE WOULD NOT HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL REQUIRED TESTING WAS PASSED PRIOR TO DISTRIBUTION. THE PATIENT INVESTIGATION DID NOT CONFIRM A CELLFINA SYSTEM DEVICE MALFUNCTIONED DURING TREATMENT, AND IT IS UNCONFIRMED WHETHER A CELLFINA SYSTEM DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. HOWEVER, MEDICAL INTERVENTION WAS ALLEGEDLY PERFORMED ON THIS PATIENT TO PREVENT PERMANENT DAMAGE TO A BODY STRUCTURE. A CONTRIBUTORY FACTOR OF THE CELLFINA DEVICES USED DURING TREATMENT COULD NOT BE RULED OUT BASED ON THE INFORMATION PROVIDED. THIS EVENT WAS DEEMED SERIOUS FOLLOWING DISCUSSION WITH THE MERZ PRODUCT SAFETY TEAM. A REVIEW OF THE CELLFINA COMPLAINT TRENDING REVEALED THE REPORTED ISSUES OF LACERATION AND VACUUM LOSS OF PRESSURE HAVE NOT OCCURRED AT A HIGH ENOUGH FREQUENCY TO GENERATE A TREND 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.

    Additional Manufacturer Narrative · 1

    THE PRACTICE REPORTED THE CELLFINA DISPOSABLE KIT USED DURING THIS TREATMENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR EVALUATION. ATTEMPTS TO OBTAIN THE LOT NUMBER OF THE CELLFINA DISPOSABLE KIT USED DURING THIS TREATMENT AND OTHER PERTINENT INFORMATION FROM THE PRACTICE MADE ON (B)(6) 2021, (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021 HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MERZ/ULTHERA RECEIVED INFORMATION FROM A PRACTICE VIA PHONE CALL ON (B)(6) 2021 REGARDING A CELLFINA ADVERSE EVENT. THE REPORTER ALLEGED THAT A PATIENT TREATED WITH THE CELLFINA SYSTEM ON (B)(6) 2021 SUSTAINED A LACERATION FROM THE TREATMENT WHICH REQUIRED STITCHES. ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE PRACTICE ON (B)(6) 2021, (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021 WERE UNSUCCESSFUL. THE PHYSICIAN THAT PERFORMED THIS PROCEDURE PHONED INTO MERZ FIELD EVENTS ON (B)(6) 2021 TO PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT. ACCORDING TO THE PHYSICIAN, WHILE PERFORMING TREATMENT ON THIS PATIENT THE CELLFINA DISPOSABLE KIT WAS LOSING VACUUM AND CAUSING THE BLADE TO CUT AT AN OBTUSE ANGLE THUS INCREASING THE SIZE OF THE INCISIONS. AFTER A COUPLE INCISIONS WERE LARGER THAN EXPECTED, THE CELLFINA DISPOSABLE KIT WAS SWAPPED OUT FOR A NEW ONE TO COMPLETE THE TREATMENT AND HE CONFIRMED THE DEFECTIVE ONE WAS DISPOSED OF. WHEN THE PROCEDURE CONCLUDED, STITCHES WERE PERFORMED ON A COUPLE INCISIONS TO ENSURE PROPER HEALING. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS TREATED ON THE REAR THIGHS ON (B)(6) 2021. A FOLLOW-UP APPOINTMENT WAS SCHEDULED WITH THE PATIENT; HOWEVER, SHE CONTRACTED COVID AND NEEDED TO RESCHEDULE FOR A NEW APPOINTMENT. HE CONTINUED THAT THE PATIENT HAS NOT CONTACTED HIM WITH ANY CONCERNS FOLLOWING TREATMENT. WHEN MORE SPECIFIC QUESTIONS REGARDING TREATMENT WERE ASKED, HE DEFERRED TO HIS NURSE AND STATED HE WOULD INSTRUCT HER TO RESPOND TO MERZ'S PREVIOUS EMAIL REQUESTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690390 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP MERZ NORTH AMERICA, INC. CK-1 US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other