5MINSKIN AT-HOME LASER HAIR REMOVAL HANDSET
Received Jan 27, 2023 · Event occurred Jan 7, 2023
Report MW5114560 · MDR key 16264745
Device
Product problems
- Energy Output Problem
Patient
44 YR · Female
- Pain
- Partial thickness (Second Degree) Burn
- Pain
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
I BOUGHT 5MIN SKIN HAIR REMOVAL DEVICE. I USED IT ON SMALL AREA (AS RECOMMENDED) NO ISSUES. I HELD THE DEVIDE OVER MY SKIN (NOT TOUCHING) USING THE "STAMP METHOD" AND PRESSED THE BUTTON IN VERY SHORT PERIODS. CONTINUED THIS SAME PATTERN (WHILE WEARING THE SAFETY GLASSES) THROUGHOUT BOTH LEGS BELOW THE KNEES. THE SETTING WAS ON THE LOWEST LEVEL (ENERGY LEVEL 1) BECAUSE IT WAS MY FIRST TIME. I DID NOT INCREASE THE LEVEL THROUGHOUT THE FIRST (AND ONLY) SESSION. THE ENTIRE PROCESS TOOK ABOUT 25 MINS FOR BOTH LEGS AS I WAS GOING SLOW. ONCE I STARTED THERE WAS ONLY A TINGLING BUT AFTER TWO HOURS, I HAD SEVERE BURNING AND RED WELTED MARKS ON BOTH LEGS. THE PAIN WAS SEVERE, I FOLLOWED DIRECTIONS, CALLED THE COMPANY, NO ANSWER. I EMAILED THE COMPANY WITH PICTURES, AND NO ONE HAS RESPONDED. I WENT TO MY PRIMARY DOCTOR ON 1/10 (EARLIEST APPT) AND WAS PRESCRIBED BURN CREAM SILVADENE TO APPLY DAILY. I HAVE A DERMATOLOGY REQUEST IN PLACE BECAUSE THEY HAVE NOT FULLY HEALED, AND I FEAR PERMANENT SCARRING.