inforMED
InjuryOHT

LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL

Received Mar 31, 2020 · Event occurred Mar 28, 2020

Report MW5093994 · MDR key 9910194

Device

Generic name

Light Based Over-the-counter Hair Removal

Manufacturer

Cyden Limited

Model number

BD5006

Catalog number

BD5006

Lot number

8334A70321

Product problems

  • Patient-Device Incompatibility

Patient

27 YR

  • Erythema
  • Itching Sensation
  • Reaction
  • Erythema
  • Itching Sensation
  • Reaction

Narrative

Description of Event or Problem

SKIN ALLERGY REACTION; I USED FDA CLEARED (AS IT SAYS ON PRODUCT) LASER HAIR REMOVAL IPL VENUS SILK BRAUN GILLETTE AND NEXT DAY I WOKE UP WITH RED BLOBS ON MY SKIN ALL OVER THE APPLICATION AREAS INCLUDING MY ARMS AND LEGS. MY SKIN LOOKS LIKE IT IS BURNT PROBABLY 1ST DEGREE AND HAS REDDISH BIG EXTENSIVE MARKS ON IT. I HAVE EXTENSIVE ITCHING TOO AND THIS PRODUCT HAS DONE MORE HARM THEN ANY GOOD. I HAVE A HEALTHY SKIN AND NEVER HAD ANY PROBLEM BEFORE. I AM A HEALTHY PERSON BUT THIS SKIN REACTION ISN'T GOOD. THESE PRODUCTS ARE HARMFUL AND NEED TO BE BANNED BASED ON RESPONSE (I CAN PROVIDE THE PHOTOS) I COULDN'T STAY AT EASE AND IT ISN'T GOING AWAY. DUE TO COVID19 SITUATION IN (B)(6) I CANNOT MEET MY PHYSICIAN AS I AM TRYING TO SELF-QUARANTINE TO HAVE SOCIAL DISTANCING. FDA SAFETY REPORT ID # (B)(4).