HOUVA II PHOTOTHERAPY SYSTEM
Received May 11, 2004 · Event occurred Apr 12, 2004
Report 1521608-2004-00001 · MDR key 525150
Device
Generic name
Ultraviolet Light Cabinet
Manufacturer
National Biological Corp.Model number
UAB-102Catalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Erythema
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
A PT HAD AN ERYTHEMAL RESPONSE TO AN ULTRAVIOLET A (PUVA) TREATMENT. PUVA TREATMENTS CONSIST OF UVA LIGHT TREATMENTS IN CONJUNCTION WITH A PHOTOSENSITIZING AGENT. IT WAS REPORTED THAT THE PT HAD TAKEN ADDITIONAL MEDICATION THAT CONTAINED PHOTOSENSITIZING AGENTS. IT WAS ALSO NOTED THAT PT MAY HAVE DOUBLED THEIR DOSE OF ONE OF THESE. THE RESPONSE OCCURRED 24-48 HOURS AFTER TREATMENT. THE PT WAS HOSPITALIZED FOR TWO DAYS AND REPORTED TO ALSO UNDERGO SOME FOLLOW-UP TREATMENTS. THERE WAS NO MISUSE OR MALFUNCTION OF THE DEVICE REPORTED.
Remedial action
- Other