HOUVA III UHU-317 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-23 for HOUVA III UHU-317 * manufactured by National Biological Corporation.

Event Text Entries

[18933731] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4673607
MDR Report Key4673607
Date Received2015-03-23
Date of Report2015-03-23
Date of Event2015-02-16
Report Date2015-03-23
Date Reported to FDA2015-03-23
Date Reported to Mfgr2015-04-09
Date Added to Maude2015-04-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHOUVA III
Generic NameLIGHT, ULTRAVIOLET, DERMATOLOGICAL
Product CodeFTC
Date Received2015-03-23
Model NumberUHU-317
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age14 MO
Device Sequence No1
Device Event Key0
ManufacturerNATIONAL BIOLOGICAL CORPORATION
Manufacturer Address23700 MERCANTILE RD. BEACHWOOD OH 44122 US 44122


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.