FDA Adverse Event Injury Summary report: N

MORPHEUS 8

MDR report key: 19752311 · Received July 15, 2024

Report

Report Number
MW5157310
Event Type
Injury
Date Received
July 15, 2024
Date of Event
January 9, 2023
Report Date
July 11, 2024
Manufacturer
INMODE LTD.
Product Code
GEI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD MORPHEUS 8 RADIOFREQUENCY MICRONEEDLING AT (B)(6) IN (B)(6), FLORIDA ON MY FACE, NECK, AND CHEST. I WAS BASICALLY BURNED FROM WITHIN. MY SKIN DID NOT HEAL PROPERLY OR BENEFIT IN ANY WAY- AND WORST OF ALL, IT WENT ON TO CAUSE SYSTEMIC DAMAGE TO MY ECM (EXTRACELLULAR MATRIX)/INTEGUMENTARY SYSTEM. FOR MONTHS, I HAD RED, BUMPY, ITCHY CHICKEN SKIN-LIKE TEXTURE, AND BURNING/HEAT SENSATION UNDER MY SKIN. IT FELT LIKE A THERMAL INJURY. I DEVELOPED HYPERPIGMENTATION FROM THE DEVICE, AND HAD GRID LIKE SCARS FROM THE SQUARE STAMP OF THE NEEDLES FROM THE DEVICE. THEN AFTER 4-6 MONTHS, I HAD SEVERE FAT LOSS IN THE AREAS TREATED- HOLLOWING UNDER EYES, CHEEKS, VEINS EXPOSED IN FOREHEAD. NECK BECAME LOOSE. THEN I BEGAN TO NOTICE THE DEGRADATION OF THE SURROUNDING TISSUES. I HAD A SYSTEMIC RESPONSE THAT CAUSED A LOSS OF SUBCUTANEOUS FAT AND COLLAGEN/ELASTIN EVERYWHERE IN THE BODY. I HAVE BEEN TORMENTED EVER SINCE THAT DEVICE WAS USED ON ME. IT SHOULD NOT BE USED BY ANYONE, IT IS A DANGEROUS DEVICE. BUT ESPECIALLY IN IRRESPONSIBLE HANDS, USED ON AN ENERGY SETTING THAT WAS WAY TOO HIGH. I WAS SEVERELY DAMAGED BY THE NURSE AT THE MED SPA USING MORPHEUS, BY INMODE. I HAVE SUFFERED PHYSICAL MENTAL AND EMOTIONAL DAMAGE, AND I HAVEN'T FOUND A WAY TO FIX IT. THEY NEED TO BE HELD ACCOUNTABLE FOR DISFIGURING ME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2165478 MORPHEUS 8 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INMODE LTD.

Patients

Seq Age Sex Outcome Treatment
1 34 YR Female Disability| R