FDA Adverse Event Injury Summary report: N

PROFOUND RF

MDR report key: 8478758 · Received April 2, 2019

Report

Report Number
MW5085519
Event Type
Injury
Date Received
April 2, 2019
Date of Event
February 28, 2019
Report Date
March 23, 2019
Manufacturer
CANDELA CORPORATION
Product Code
GEX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

HAD "LITIQUE OF FACE AND NECK, LIPOSUCTION OF NECK" DONE AT (B)(6). THE PROCEDURE USES A COMBINATION OF RADIO FREQUENCY TECHNOLOGY WITH DERMA STAMPING TO CORRECT LOOSE SKIN. MY FACE WAS INFLAMED AND SWOLLEN TWICE THE SIZE OF MY NORMAL BUT I WAS TOLD THAT WAS EXPECTED. THE SKIN WAS COVERED WITH AQUAPHOR OINTMENT AND I WENT HOME AFTER THE PROCEDURE. I NOTICED THE PRESENCE OF WHITE PIN-HEAD SIZE RAISED BUMPS WHERE DERMA STAMP WAS DONE AND NOTIFIED MY COSMETIC DR, DR. (B)(6) ON (B)(6) 2019, HE SUGGEST TO APPLY OTC HYDROCORTISONE CREAM THAT WAS STARTED. NEXT 10 DAYS, REDNESS AND EDEMA SLOWLY DECREASED. (B)(6) CONDITION DID NOT IMPROVE, CONTACTED THE DR, HE ORDERED TRIAMCINOLONE 0.5% CREAM. ON (B)(6) 2019, CONDITION DOES NOT IMPROVE AND STARTED MEDROL 4MG DOSEPACK ON (B)(6) 2019. AS OF TODAY, (B)(6) 2019 RAISED BUMPS ON MY NECK ARE LESS RAISED BUT VISIBLE, LEFT CHEEK NEW BUMPS STARTED TO APPEAR THE NIGHT OF (B)(6) 2019. I HAVE APPT TO SEE DR (B)(6) ON MONDAY, (B)(6) 2019. I BELIEVE MY CONDITION IS ALLERGIC FOREIGN BODY GRANULOMAS, BUT THAT IS MY EDUCATED "GUESS" FROM RESEARCHING THE CONDITION. I AM RETIRED REGISTERED NURSE ((B)(6)), I HAVE RESEARCHED TOPICS OF SAFETY AND ADVERSE REACTION TO MICRO NEEDLING AND ALL I SEE IS THAT IT IS RARE FOR ADVERSE REACTION. WE NEED TO PROTECT OURSELVES FROM MED-SPA CLINIC WHERE ANY MDS CAN OPEN THE LUCRATIVE BUSINESS WITH MINIMAL TRAINING AND EXPERIENCES. PLEASE MAKE THOSE ADVERSE REACTIONS REPORTABLE TO FDA SO THAT CONSUMERS CAN ABLE TO SEE THE RISK. THANK YOU. TO ME, THIS IS CAUSED BY POSSIBLY ELECTRIC CONDUCTOR JELL INJECTED DEEP INTO MY SKIN BY DERMA STAMP DEVICE. PROFOUND RF (CANDELA) THAT MY IMMUNE REACTION TO SUBSTANCE. AQUAPHOR OINTMENT ENTERED VIA NEWLY CREATED CHANNEL HOLE TRIGGERED MY HYPERACTIVE IMMUNE REACTION. I AM NOT A DR BUT THOSE ARE THE INFO I READ IN PROCESS OF FINDING CURE FOR MY CONDITION. I THINK IT WAS RESULT OF BAD PROTOCOL. THANK YOU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
266695 PROFOUND RF POWER LASER SURGICAL INSTRUMENT GEX CANDELA CORPORATION

Patients

Seq Age Sex Outcome Treatment
0 Required Intervention