RADIOLOGIST FREQUENCY MICRONEEDLER
Received Nov 7, 2025 · Event occurred Mar 14, 2025
Report MW5178679 · MDR key 23500413
Device
Generic name
Powered Microneedle Device
Manufacturer
UnknownProduct problems
- Patient Device Interaction Problem
Patient
49 YR · Female
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
- Blister
- Skin Inflammation/ Irritation
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
- Blister
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
I WENT TO A REPUTABLE MED SPA TO HAVE A SUBLATIVE PROCEDURE DONE (THURSDAY). BEFORE THE APPOINTMENT, I WAS ASSURED THAT THE DOWNTIME WOULD BE MINIMAL, AND MY SKIN WOULD HEAL BEAUTIFULLY. THE DAY OF THE PROCEDURE CAME AND THE TECHNICIAN SAID THAT THEY WOULD START WITH THE LOWEST FREQUENCY. AFTER THE PROCEDURE, MY SKIN FELT WARM, BUT I WAS TOLD THAT IT IS NORMAL. THE NEXT DAY (FRIDAY), THE SPOTS WHERE THE MICRO NEEDLING WAND WAS PLACED, MY SKIN STARTED TO RAISE AND BLISTER. BY THE NEXT DAY (SATURDAY), MY FACE WAS SWOLLEN AND THE PATCHES WERE BRIGHT RED. I CONTACTED THE TECHNICIAN, AND SHE SAID THAT I WAS HAVING AN ALLERGIC REACTION AND TO TAKE BENADRYL. THAT NIGHT, MY FACE WAS SO SWOLLEN THAT I COULDN'T SEE AND HAD TO GO TO THE ER. THE ER REFERRED ME TO A BURN CLINIC, AND THE CLINIC SAID THAT I HAD RECEIVED 2ND DEGREE BURNS TO MY FACE AND NECK.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 12/4/2025 FOR REPORT MW5178679 THAT PATIENT DID NOT RECEIVED A 3RD DEGREE BURN AND TO REMOVE CODE 2696.