BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS8

    MDR report key: 20202341 · Received September 11, 2024

    Report

    Report Number
    MW5159529
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    December 5, 2023
    Report Date
    September 7, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    PBX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HELLO, WENT TO (B)(6) REJUVENATION CENTER IN (B)(6). I WAS RECOMMENDED BY (B)(6) TO HAVE MORPHEUS8 TREATMENT TO HELP TREAT MY FACE FROM DROPPING DOWNWARDS, THIS MACHINE CONSISTS OF HOT NEEDLES AND THE SETTING CAN BE VERY DANGEROUS TO THE AREAS THAT ONE IS TREATING, SO I WAS A REGULAR AT THIS FACILITY FOR 6 YEARS, AND SO I TRUSTED THEM COMPLETELY. WELL, LITTLE DID I KNOW ON DECEMBER 5TH CHANGED MY LIFE FOREVER. (B)(6) WAS THE PROVIDER THAT DONE THIS PROCEDURE AND LITERALLY MELTED MY FACE CAUSING SEVERE FACIAL DAMAGE ESPECIALLY TO MY RIGHT EYE, SHE USED THE NEEDLE DEPTH ON 2.6 ON MY THIN FACE AND ALSO UNDER BOTH EYES, IN MY MEDICAL RECORDS FROM MY EYE DOCTOR SAYS THAT I GOT BLUNT FORCE TRAUMA TO MY RIGHT EYE. THIS IS WHERE I FELT THE NEEDLE PENETRATE THROUGH MY RIGHT EYE. AND NOW I HAVE BUSTED CAPILLARIES ALL OVER MY FACE AND I HAVE MUSCLE SPASMS AROUND MY MOUTH CAUSING MY MOUTH TO FLY OPEN WHERE I CAN'T CONTROL IT. ALSO, MY RIGHT SIDE OF MY FACE IS CAVED IN, SO I HAVE ASKED FOR MY MEDICAL RECORDS SO MANY TIMES THAT THEY HAVE IN FACT DENIED ME FROM THEM, I HIRED AN ATTORNEY AND FOR 6 MONTHS HE CONTINUED IN TRYING TO GET MY MEDICAL RECORDS FROM THIS FACILITY AND THEY KEPT TURNING HIM DOWN. SO, WHEN MY EYE DOCTOR ASKED FOR MY MEDICAL RECORDS FROM (B)(6) THEY SENT THEM OVER AND THE RECORDS STATE THAT THERE WERE NO WRONG DOINGS, BUT IT DOESN'T HAVE THE ACCURATE DEPTH SETTING SHE USED IN DETAIL. SO, I KNOW FOR A FACT THAT THEY HAVE CHANGED MY MEDICAL RECORDS. I HAD IT DONE BACK IN DECEMBER AND THEN I WENT BACK TO TALK TO THE PLASTIC SURGEON FROM THIS FACILITY AND HE BLAMED ME FOR LOSING WEIGHT WHICH I HAVE RECORDS THAT'S NOT TRUE. SO, WHEN I GOT UP TO LEAVE, I ASKED FOR MY MEDICAL RECORDS AGAIN AND THEY REFUSED ME AGAIN. SO, 3 DAYS LATER I CALLED THE DR. (B)(6) NURSE AND SHE IN FACT STATED TO ME THAT (B)(6) HAD INDEED USED 2.6 ON MY THIN FACE. THIS NEEDLE DEPTH IS USED FOR THE BODY NOT ONES FACE. SO NOW THIS FACILITY TOLD ME. FOR ME NOT TO SHOW UP AND THEY ALSO HAVE (B)(6) THAT THEY WON'T GIVE ME BACK. SO PLEASE WHOEVER IS READING THIS. PLEASE HELP ME IN MY TIME OF NEED. THANK YOU & GOD BLESS!!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112378 MORPHEUS8 MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT PBX INMODE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other INHALER.| VITAMIN D.| VITAMIN E.| VITAMIN.| WELLBUTRIN.