inforMED
MalfunctionFTC

HOUVA III

Received Mar 23, 2015 · Event occurred Feb 16, 2015

Report 4673607 · MDR key 4673607

Device

Generic name

Light, Ultraviolet, Dermatological

Model number

UHU-317

Catalog number

*

Lot number

*

Product problems

  • Improper Device Output

Patient

*

  • Burn(s)

Narrative

Description of Event or Problem

REPORTEDLY, THREE PATIENTS UNDERGOING PHOTOTHERAPY TREATMENT WERE FOUND TO HAVE SUNBURN AT THEIR FOLLOW-UP APPOINTMENTS. THEY DID NOT REQUIRE TREATMENT. THE PHOTOTHERAPY BOOTH WAS CLOSED AND UNDERWENT FULL MAINTENANCE INCLUDING REPLACEMENT OF THE SENSORS AND UVB LAMPS. THE PHOTOTHERAPY BOOTH WAS RE-OPENED.