DEMI PLUS 910860-1

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 PLUS 910860-1 manufactured by Kerr Corporation.

Event Text Entries

[4823421] A doctor alleged that multiple patients had experienced sensitivity after light curing the composite with demi plus. This is the fourth of five (5) reports.
Patient Sequence No: 1, Text Type: D, B5


[12271859] Specific patient information with regard to age, gender and weight was not provided by the office. Although the doctor identified two (2) different demi plus units associated with the sensitivity issues, the doctor could not verify which unit was used on any of the patients; therefore, no serial numbers were identified in this report. The units involved in the alleged incident include serial number (b)(4). The doctor removed the composite and placed zinc-oxide eugenol to calm the sensitivity for the patient. To date, the patient is doing fine. The devices involved in the alleged incidents have not been returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2024312-2014-00534
MDR Report Key3984898
Report Source05
Date Received2014-08-06
Date of Report2014-07-09
Date Mfgr Received2014-07-09
Date Added to Maude2014-08-06
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 ContactMS. KERRI CASINO
Manufacturer Street1717 W COLLINS AVE.
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
Manufacturer G1KERR CORPORATION
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal Code92867
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEMI PLUS
Generic NameULTRAVIOLET ACTIVATOR FOR POLYMERIZATION
Product CodeEBZ
Date Received2014-08-06
Catalog Number910860-1
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKERR CORPORATION
Manufacturer Address1717 W COLLINS AVE ORANGE CA 92867 US 92867


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-08-06

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