BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 10226290 · Received July 2, 2020

    Report

    Report Number
    3006560326-2020-00006
    Event Type
    Injury
    Date Received
    July 2, 2020
    Date of Event
    March 6, 2020
    Report Date
    July 29, 2020
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OUP
    PMA / PMN Number
    K192185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS NOT PERFORMED AS THE PRACTICE STATED THAT THE CELLFINA DISPOSABLE KIT USED DURING TREATMENT WAS NOT AVAILABLE FOR RETURN. THE PHYSICIAN STATED THAT THE EQUIPMENT PERFORMED AS INTENDED DURING TREATMENT, AND NO INFORMATION WAS OBTAINED DURING THE INVESTIGATION THAT WOULD INDICATE A MALFUNCTION OCCURRED. AN EVALUATION OF THE SERVICE HISTORY OF THE CONTROL MODULE USED DURING TREATMENT WAS NOT PERFORMED AS CELLFINA DEVICES ARE NOT SERVICEABLE EQUIPMENT. AN EVALUATION OF THE LOT COMPLAINT HISTORY WAS NOT PERFORMED AS THE LOT NUMBER OF THE CELLFINA DISPOSABLE KIT WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE CELLFINA SYSTEM CONTROL MODULE REVEALED A NON-CONFORMANCE WAS OPENED TO ADDRESS INCORRECT SPECIFICATIONS FOR LOAD VOLTAGE TESTS. THE NON-CONFORMANCE WAS FOUND TO BE A DOCUMENTATION ERROR AND DETERMINED TO HAVE NO POTENTIAL IMPACT ON THIS EVENT. NO DEVIATIONS OR REWORK WERE NOTED DURING THE MANUFACTURE OF THIS DEVICE, AND ALL REQUIRED TESTING WAS PASSED PRIOR TO DISTRIBUTION. THE PATIENT INVESTIGATION FOUND THE CELLFINA SYSTEM DEVICES USED DURING TREATMENT DID NOT MALFUNCTION. IT IS UNCONFIRMED WHETHER A CELLFINA SYSTEM DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. HOWEVER, PERMANENT DAMAGE TO A BODY STRUCTURE 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 PATIENT COMPLAINT TRENDING REPORT REVEALED THAT NONE OF THE REPORTED ISSUES OF ANXIETY, BLEEDING, BRUISING/ECCHYMOSIS, LACERATION, SCAR (MINOR), OR TENDERNESS/SORENESS/PAIN/SENSITIVITY TO TOUCH HAVE 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.

    Description of Event or Problem · 0

    MERZ/ULTHERA RECEIVED A FOLLOW-UP REPORT FROM THE PATIENT VIA EMAIL ON 05-JUL-2020 REGARDING THIS CELLFINA ADVERSE EVENT. THE REPORTER STATED, "I HAD THE PROCEDURE DONE (B)(6) 2020. THE ONLY REASON I HAVEN'T WRITTEN MORE IS BECAUSE I AM TRYING HARD TO WORK WITH THE PROVIDER. I MET WITH THE DOCTOR ABOUT A MONTH AGO NOW AND HE AGREED TO REFUND THE PRICE AND OFFERED TO HAVE HIS OFFICE TREAT THE SCARS. I ASKED FOR REIMBURSEMENT FOR AN ESTIMATE I RECEIVED FROM A PLASTIC SURGEON; HE SAID HE WOULD HAVE TO TALK TO SOMEONE. THEN I GOT AN EMAIL SAYING THAT THEY WOULD NOT COVER THE REPAIR BY THE PLASTIC SURGEON BUT THAT I COULD GET REPAIR BY THEM. HE HAS NOT REFUNDED THE COST OF THE CELLFINA AS HE STATED HE WOULD. I HAVE SENT A FINAL EMAIL TO REQUEST THIS. I NEED TO HAVE THE REPAIR DONE SO IF HE WILL KEEP HIS WORD AND REFUND THE COST THAT WILL HELP WITH THE REPAIR. I WILL SHARE THE INFORMATION SOON. I'M SURE YOU WANT TO FOLLOW UP ON ANY PROVIDERS NOT USING YOUR EQUIPMENT PROPERLY. THE PLASTIC SURGEON AND HIS ASSISTANT AGREED THAT, IN THEIR OPINION, IT WAS USER ERROR WITH THE MACHINE." ON (B)(6) 2020, THE PHYSICIAN THAT TREATED THE PATIENT PROVIDED ADDITIONAL INFORMATION REGARDING THE EVENT. THE PHYSICIAN STATED THE PATIENT WAS TREATED ON THE BUTTOCKS AND POSTERIOR THIGHS, AND CONFIRMED THAT DURING TREATMENT THE PATIENT EXPERIENCED PAIN AND REQUIRED A SECOND DOSE OF ANESTHESIA. IMMEDIATELY FOLLOWING TREATMENT, THE PATIENT WAS BLEEDING AND REQUIRED COMPRESSION OF THE TREATMENT AREA FOR APPROXIMATELY 30 MINUTES. THE PHYSICIAN STATED HE DIRECTED TO PATIENT TO USE SILICONE GEL TO PREVENT SCARRING; HOWEVER, NOTED THE PATIENT DID NOT USE IT. THE PHYSICIAN STATED THAT HE FELT THE SCARRING WAS MILD AND OFFERED SCAR REVISION TREATMENT FOR FREE, BUT THE PATIENT DID NOT SCHEDULE. ON 29-JUL-2020, THE PATIENT SENT A FOLLOW-UP EMAIL CONTAINING MORE INFORMATION STATING "THE PROCEDURE WAS EXTREMELY PAINFUL AND I QUESTIONED THE ANESTHETIC. I LET THEM KNOW HE AND ASSISTANTS THAT AT THE DENTIST IT ALWAYS TAKES LIDOCAINE A LONGER TIME TO TAKE EFFECT AND WE LET IT SIT IN MY MOUTH FOR LONGER THAN USUAL. DURING THE PROCEDURE I QUESTIONED THE PROCEDURE DUE TO IT BEING SO PAINFUL; STATING THAT IT WAS HURTING VERY BADLY AND ASKING IF THE MACHINE WAS WORKING PROPERLY. AT ONE POINT THE ASSISTANT ASKED ME ABOUT THE PAIN, SHE SAID YOU SEEM TO BE CALLING OUT (IN PAIN) AT THE END OF THE CUT. I TOLD HER YES ABSOLUTELY, IT FEELS AS IF EDGE OF IT GETTING CAUGHT ON MY SKIN. THE WOUNDS ARE CONGRUENT WITH THIS. BACK TO PROCEDURE DAY, ABOUT THREE-QUARTERS OF THE WAY THROUGH MY LEGS BEGAN SHAKING LIKE THEY DID WHEN I WAS IN LABOR. IT SHOULD BE NOTED THAT I HAVE A HIGH PAIN TOLERANCE. AFTER SURGERY I HAD TO STAY IN EXTENSIVE BANDAGES FOR 4 DAYS, WITH LESSER BANDAGES FOR 2 WEEKS. DURING THE 2 WEEKS, TO INCLUDE AT THE END OF THE 2 WEEKS I WAS STILL BLEEDING. IN FACT, BLEED THROUGH BANDAGES ONTO MY CHAIR AT WORK. I ALSO BLED DOWN THE SIDE OF THE TOILET THAT SECOND WEEK. IT HAS IMPROVED CERTAINLY. BUT IT HAS CAUSED ME ANXIETY, I MIGHT EVEN SAY ANGUISH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED THUS FAR; NO MALFUNCTIONS OF A CELLFINA DEVICE WERE ALLEGED. UNSUCCESSFUL ATTEMPTS TO GATHER INFORMATION REGARDING THE PRACTICE DETAILS AND TREATMENT DATE WERE PERFORMED ON 11-JUN-2020 AND 02-JUL-2020. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MERZ/ULTHERA RECEIVED A REPORT FROM A PATIENT VIA EMAIL ON (B)(6) 2020 REGARDING A CELLFINA ADVERSE EVENT. THE REPORTER STATED, "HERE ARE SOME PHOTOS OF MY BUTT/LEGS SINCE A MEDICAL DOCTOR PERFORMED CELLFINA ON ME. DO YOU CARE THAT HE IS DOING THIS TO PEOPLE? I HAVE ASKED FOR THE DOCTOR TO PAY FOR A PLASTIC SURGEON TO REPAIR IT AND HE REFUSES. I HAVE DEEP SCARRING 3+ MONTHS POST TREATMENT. I HAVE CONSULTED A PLASTIC SURGEON AND OTHER CELLFINA EXPERTS WHO SAY THAT THE MACHINE WAS USED INCORRECTLY. I WANT MY LEGS RESTORED." NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688074 THE CELLFINA SYSTEM THE CELLFINA SYSTEM OUP MERZ NORTH AMERICA, INC. CK-1 US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EPINEPHRINE| LIDOCAINE WITH BICARBONATE