VALO CURING LIGHT 5919

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-29 for VALO CURING LIGHT 5919 manufactured by Ultradent Products Inc.

Event Text Entries

[6045104] Dds alleged that two patients were burned on the outside of the cheek from the valo curing light while curing sealents on tooth #19. Neosporin was used. This is the second of two reports.
Patient Sequence No: 1, Text Type: D, B5


[13304896] After extensive testing on the returned unit it was concluded that the curing light did not get hot enough to create a burn under normal use, but becasue intervention was performed by applying (b)(6) to the the affected area this even is reportable as per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1718912-2015-00003
MDR Report Key4874802
Report Source05
Date Received2015-06-29
Date of Report2015-06-16
Date of Event2015-04-08
Date Mfgr Received2015-04-06
Device Manufacturer Date2015-04-19
Date Added to Maude2015-06-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. RONA MURPHY
Manufacturer Street505 WEST 10200 SOUTH
Manufacturer CitySOUTH JORDAN UT 84095
Manufacturer CountryUS
Manufacturer Postal84095
Manufacturer Phone8005525512
Manufacturer G1ULTRADENT PRODUCTS INC
Manufacturer Street505 WEST 10200 SOUTH
Manufacturer CitySOUTH JORDAN UT 84095
Manufacturer CountryUS
Manufacturer Postal Code84095
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVALO CURING LIGHT
Generic NameCOMPOSITE CURING LIGHT
Product CodeEBZ
Date Received2015-06-29
Returned To Mfg2015-04-27
Model Number5919
Catalog Number5919
Lot NumberB5YLG
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerULTRADENT PRODUCTS INC
Manufacturer Address505 WEST 10200 SOUTH SOUTH JORDAN UT 84095 US 84095


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-06-29

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