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 LimitedModel number
BD5006Catalog 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).