TRANSLUX? POWER BLUE 66017507

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-01-10 for TRANSLUX? POWER BLUE 66017507 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[4048145] This is the third of six reports involving 6 different devices and 4 patients. A dental office has a curing light that they said is not curing properly. They have had to remove and re do 6 fillings so far. On (b)(6) 2013 spoke with assistant. She said that they only had 4 patients involved. She said that they would try the lights and when they did not cure they would grab another light and try it. They did not reuse it once it failed to cure. She said that they tried to cure for 40 seconds but the composite was still soft. She said that the lights did not seem to have enough curing power to cure the composite.
Patient Sequence No: 1, Text Type: D, B5


[11367164] (b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Device has not been received for testing. Evaluation pending return of complaint unit.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005665377-2014-00003
MDR Report Key3567333
Report Source05,07
Date Received2014-01-10
Date of Report2013-12-11
Date Facility Aware2013-12-11
Date Mfgr Received2013-12-11
Date Added to Maude2014-01-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTAL ASSISTANT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. AUDI BOGUCKI
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER GMBH
Manufacturer StreetGRUNER WEG 11
Manufacturer CityHANAU, D-63450
Manufacturer CountryGM
Manufacturer Postal CodeD-63450
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRANSLUX? POWER BLUE
Generic NameACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Product CodeEBZ
Date Received2014-01-10
Catalog Number66017507
OperatorDENTIST
Device AvailabilityN
Device Age20 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressGRUNER WEG 11 HANAU, D-63450 GM D-63450


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-01-10

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