InjuryFTC
UV PHOTOTHERAPY
Received Jan 25, 2021 · Event occurred Jan 16, 2021
Report MW5099003 · MDR key 11229246
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
UnkProduct problems
- Product Quality Problem
Patient
Not reported
- Itching Sensation
- Burn, Thermal
- Itching Sensation
- Burn, Thermal
Narrative
Description of Event or Problem
I BOUGHT A LAMP FROM (B)(6). I USED IT FOR A FEW DAYS AND FOUND IT TO BE OVERLY DRYING AND MADE ME INCREDIBLY ITCHY, AND IT ALSO BURNED MY SKIN BADLY AND HAVE TO GO TO HOSPITAL. IT SAYS THAT THIS IS A PRESCRIPTION (RX) MEDICAL DEVICE IN ITS PACKAGE AND MANUAL. WHY IT IS AVAILABLE ON (B)(6) FOR SALE TO INDIVIDUAL LIKE ME WITHOUT PRESCRIPTION. IT SHOULD BE RESTRICTED ON (B)(6). FDA SAFETY REPORT ID # (B)(4).