inforMED
MalfunctionOHT

LASERAWAY HAIR REMOVAL CLINIC

Received Apr 8, 2022

Report MW5108881 · MDR key 14075242

Device

Generic name

Light Based Over-the-counter Hair Removal

Manufacturer

Unk

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

45 YR · Female

  • Scar Tissue
  • Skin Inflammation/ Irritation
  • Scar Tissue
  • Skin Inflammation/ Irritation

Narrative

Description of Event or Problem

I HAD TREATMENT DONE FOR HAIR REMOVAL ON MY FACE AT THE (B)(6) LOCATION IN 2021. AFTER TREATMENT WAS OVER I NOTICED REDNESS AND SCARRING ON MY FACE THAT HAS NOT GONE AWAY FOR 3 MONTHS NOW. DURING CONSULTATION THERE WAS NO MENTION OF POSSIBLE SCARRING ONLY THAT NOT ALL THE HAIRS WILL BE GONE. BEFORE AND AFTER EACH TREATMENT I RIGOROUSLY FOLLOWED THE INSTRUCTIONS OF NO SUN EXPOSURE WITHOUT SUNSCREEN. AS A MATTER OF FACT, I ALWAYS ENSURED I WAS NOT EXPOSED TO ANY SUN BEFORE OR AFTER MY TREATMENT, FOR A FEW DAYS. THIS COMPLAINT IS RELATED TO THE FACT THAT NOBODY MENTIONED POSSIBLE SCARRING. I WOULD NEVER HAVE HAD THIS TREATMENT IF I KNEW THIS MIGHT HAPPEN. NOW I HAVE SCARRING ON MY FACE PERMANENTLY. THERE NEEDS TO BE A WARNING AND PART OF CONSULTATION ABOUT THIS.