FDA Adverse Event Injury Summary report: N

MORPHEUS 8

MDR report key: 19584965 · Received June 20, 2024

Report

Report Number
MW5156445
Event Type
Injury
Date Received
June 20, 2024
Date of Event
May 5, 2022
Report Date
June 16, 2024
Manufacturer
INMODE LTD.
Product Code
GEI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NL
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD MORPHEUS 8 RADIO-FREQUENCY MICRONEEDLING FOR MY ACNE SCARS, MADE BY INMODE LTD, AN ISRAELI COMPANY. AFTER THREE SESSIONS, I EXPERIENCED SIGNIFICANT CHANGES IN MY FACIAL APPEARANCE, CHARACTERIZED BY VOLUME LOSS, SKIN AND FAT ATROPHY, AND THE EMERGENCE OF NEW FAT DEPOSITS. THE PAIN IN MY CHEEKS AND UPPER LIP PERSISTED, ACCOMPANIED BY A SENSATION OF TIGHTNESS AND THICKNESS IN MY SKIN, SUGGESTIVE OF SCAR TISSUE COLLAGEN ACCUMULATION. I ALSO EXPERIENCED EXTREME FATIGUE, HEADACHES, DIZZINESS, CHARACTERISTIC OF A SEVERE IMMUNE SYSTEM RESPONSE TO THE THERMAL INJURY TO THE SKIN, THAT LEFT ME BEDRIDDEN FOR MONTHS, EVEN YEARS. I FIND MYSELF IN EXTREME EMOTIONAL AND PHYSICAL DISTRESS. THE CLINIC DENIED RESPONSIBILITY, LEADING TO A CONFRONTATION INVOLVING LEGAL THREATS AND INTIMIDATION TACTICS. THEIR STAFF DOES NOT SEEM TRAINED OR EDUCATED TO OPERATE THESE DEVICES. I DO NOT THINK THEY REPORTED MY INJURIES TO THE PROVIDER OF THE DEVICE INMODE LTD., INSTEAD, THEY SEND ME AN E-MAIL THREATENING ME WITH A LIBEL LAWSUIT IF I SHARE MY STORY PUBLICLY OR IF I SAY ANYTHING ABOUT INMODE LTD. IT SEEMS THAT THE PROVIDER (INMODE) TRAINS CLINICS IN AGGRESSIVE TACTICS AGAINST VICTIMS, WHEN THOSE COME FORWARD. AFTER THIS, MY EMOTIONAL DISTRESS GOT WORSE AND I NEVER MADE ANOTHER ATTEMPT AT REPORTING MY INJURIES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2178235 MORPHEUS 8 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INMODE LTD.

Patients

Seq Age Sex Outcome Treatment
1 33 YR Female Other| S THE USUAL MULTIVITAMINS.