FDA Adverse Event Injury Summary report: N

INMODE MORPHEUS 8

MDR report key: 20269112 · Received September 19, 2024

Report

Report Number
MW5159802
Event Type
Injury
Date Received
September 19, 2024
Date of Event
April 26, 2022
Report Date
September 17, 2024
Manufacturer
INMODE LTD.
Product Code
GEI
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
ME, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2022 STARTED TREATMENTS WITH MORPHEUS 8 TO REDUCE FINE LINE AND WRINKLES IN MY FACE. IN THE INITIAL SESSION, THE PROVIDER PERFORMED MICROBLADING OF MY EYEBROWS, INJECTED 20 UNITS OF XEOMIN IN MY GLABELLAR AND MORPHEUS 8 ON MY ENTIRE FACE AND NECK. DURING THE SECOND TREATMENT ON (B)(6) 2022, I HAD ASKED ABOUT A HORRIBLE BURNING SMELL TO WHICH I WAS TOLD WAS THE HAIR ON MY FACE BURNING OFF. THE NEXT DAY, I HAD A LARGE BROWN LEATHERY PATCH ON THE RIGHT SIDE OF MY CHIN AND WAS ADVISED TO APPLY CREAM TO HELP WITH HEALING. THAT PATCH LASTED FOR SEVERAL MONTHS BEFORE IT FADED. DURING THAT SESSION, I HAD HORRIBLE "SHOCK LIKE" PAIN IN MY NECK AND I ASKED HER TO STOP. FROM THAT I HAD SEVERAL DEEP PUNCTURE WOUNDS IN MY NECK THAT TOOK WEEKS TO HEAL. MY LAST MORPHEUS 8 TREATMENT WAS ON (B)(6) 2022. THE PERSON PERFORMING THE PROCEDURE DID NOT TAKE ANY PHOTOS OF THE TRANSFORMATION OTHER THAN ON (B)(6) 2022 (CONSULTATION) AND ON (B)(6) 2022 (DAY OF THE PROCEDURE), YET SHE NOTED THAT IT WAS "AMAZING." IT WAS FAR FROM AMAZING. WITHIN A FEW MONTHS I BEGAN TO NOTICE THAT MY FACE WAS DROOPING, PARTICULARLY AROUND MY EYES. TWO YEARS LATER AND I HAVE LOST A TREMENDOUS AMOUNT OF VOLUME AND LAXITY IN MY ENTIRE FACE. MY TEMPLES ARE HOLLOWED AS ARE MY EYES. THE LEFT SIDE OF MY FACE IS MORE DAMAGED CAUSING MY LEFT EYE TO HAVE A FOLD IN IT DESPITE HAVING BLEPHAROPLASTY IN (B)(6) 2022. IN FACT, BOTH OF MY EYES ARE DROOPING AGAIN AS MY ENTIRE FACE HAS SUNKEN AND SAGS. I WENT TO A PLASTIC SURGEON WHO HAS ADVISED THAT ONLY A FACE LIFT WILL REPAIR THE DAMAGE TO MY SKIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1449449 INMODE MORPHEUS 8 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INMODE LTD.

Patients

Seq Age Sex Outcome Treatment
1 52 YR Female Other DAILY VITAMIN.| XEOMIN.