DERMALIGHT 80UV-B WAND / DERMARAT UV-B WAND *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-23 for DERMALIGHT 80UV-B WAND / DERMARAT UV-B WAND * manufactured by Total Control Pty. Ltd..

Event Text Entries

[15182880] In 2005, i used a product called the dermalight 80 uv-b wand for the treatment of psoriasis. I used the dermalight 80 uv-b wand a few times according to the instruction. I stopped using the product immediately after i noticed the severe loss of elasticity to the areas of skin that i applied treatment to. Later, i noticed pain in and damage to my eyes even though i utilized the protective eye-wear. I later returned the product to the mfr. The product is sold and distributed by an (b) (4) company called total control pty. Ltd. They advertise this product, which is now sold under a different name called the dermaray uv wand, on the (b) (4) website. They also advertise similar uv-b devices called the dermaray hair loss laser comb, and even a full body device called the dermaray canopy 10. These products are advertised and sold for the treatment of psoriasis and hair loss on the (b) (4). Our skin is a major organ of our body, and is a part of our intricate organ and endocrine system. This medical uv-b device, the dermalight 80, now called the dermaray, has adversely affected my epidermis in an irreversible way. Which has subsequently, adversely affected my total well-being. The wand emits ionizing uv-b radiation at the wavelength of 311nm. It is thought to be safe because the ionizing energy is emitted in a narrowband or in a straight line, however, this does not take into consideration a total uv-b dose to the entire body over a life time. In other words, once utilizing a uv-b device for treatment of psoriasis on one part of their body can become photosensitive or over-exposed to uv-b radiation overtime as additional exposure to the sun's uv radiation occurs. This is known as cumulative dose. In addition, our scalp protects our brains and is extremely close to our face and eyes, one should never expose their scalp, face, eyes, brain nor their entire body to the extremely ionizing uv-b radiation of the dermalight 80, the dermaray uv wand, the dermaray hair loss laser comb, the dermaray canopy 10 or any other uv-b emitting device. The science behind uv radiation and it's adverse affects on human skin and eyes has been well researched and documented by scientists and researchers. Had i known this science at the time i purchased and utilized the uv-bd device, i would have never have purchased it and used it. As a steward of this earth i am writing this report in hopes of protecting others from using these uv-b devices. In addition, i am asking for the fda to take all uv-b devices for the treatment of skin disorders and hair loss off the market. Mankind had unknowingly contributed to the immense damage of our ozone layer, decades later, we are now knowledgeable and working towards preventing further damage. As the fda is the legal regulating agency for these medical devices, the fda has the responsibility and authority to protect the people of the untied states from hazardous uv-b radiation emitting devices. I ask that the fda not only send out a health alert on these uv-b devices but to take them off the market in the united states.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5016074
MDR Report Key1700418
Date Received2010-05-23
Date of Report2010-05-23
Date of Event2005-05-01
Date Added to Maude2010-06-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDERMALIGHT 80UV-B WAND / DERMARAT UV-B WAND
Generic NameUV-B 311NM NARROWBAND MEDICAL DEVICES
Product CodeFTC
Date Received2010-05-23
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerTOTAL CONTROL PTY. LTD.
Manufacturer AddressPO BOX 154 BALLAJURA, WESTERN AUSTRALIA 6066 AS 6066


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2010-05-23

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