DEMI 910770

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 2014-08-06 for DEMI 910770 manufactured by Kerr Corporation.

Event Text Entries

[15123314] A doctor's office alleged that upon removal of the light guide, the demi curing light had shocked the doctor.
Patient Sequence No: 1, Text Type: D, B5


[15292121] The doctor unplugged the unit and returned it for evaluation. No serious injury was associated with this incident. No medical attention or prescription medication was required. To date, the doctor is doing fine. A visual and physical evaluation was performed on the returned device. It was discovered that the unit had power, but the switch would not turn on the curing light. The incident which occurred could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2024312-2014-00554
MDR Report Key3984940
Report Source05
Date Received2014-08-06
Date of Report2014-07-07
Date Mfgr Received2014-07-07
Date Added to Maude2014-08-15
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. KERRI CASINO
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167623
Manufacturer G1KERR CORPORATION
Manufacturer Street1717 WEST COLLINS AVE.
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal Code92867
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEMI
Generic NameACTIVATOR,ULTRAVIOLET,FORPOLYMERIZATION
Product CodeEBZ
Date Received2014-08-06
Catalog Number910770
OperatorDENTIST
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKERR CORPORATION
Manufacturer Address1717 WEST COLLINS AVE. ORANGE CA 92867 US 92867


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-08-06

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