HELIOMOLAR CAVIFIL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-03 for HELIOMOLAR CAVIFIL manufactured by Ivoclar Vivadent, Inc..

Event Text Entries

[1077521] Dentist advised that -2- very old fillings, on -2- upper back molars should be replaced. My molars did not have pain, sensitivity, cracks or anything wrong with them. By early 2009, returned to dentist with pain, sensitivity coming from the filled teeth. Sensitivity was confirmed, additional x-rays taken, with no visible signs of any cracks in the teeth. Referred to endodontist. Acute sensitivity detected and root canal performed on one of the molars. No cracks were seen in any of the dental xrays and an explanation could not be given for what happened. The second molar, a wisdom tooth had the same problem. Instead of a root canal, opted to have it extracted. Checked with the dentist on filling material used so, i could find an explanation for myself. The name of the product is heliomolar hb, cavifil, dental composite filling material. The dentist contacted the manufacturer and found no ingredients had changed. I looked up any adverse reactions but found none, just an issue with another product by this manufacture, but not the cavifil. I thought i would report this because i cannot find another reason for what happened to my molars. Had to go through many pain pills, inflammatory medicines and two doses of antibiotics since i had to be put on a stronger one through this whole ordeal. I would like to know if there are any other complaints about this product so, i know what to do next time i need a filling replaced. Dates of use: 2009. Diagnosis or reason for use: dental filling material used on molars. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5010174
MDR Report Key1334370
Date Received2009-03-03
Date of Report2009-03-03
Date of Event2009-01-13
Date Added to Maude2009-04-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHELIOMOLAR CAVIFIL
Generic NameDENTAL FILLING MATEIRAL
Product CodeEBD
Date Received2009-03-03
OperatorOTHER
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerIVOCLAR VIVADENT, INC.
Manufacturer Address175 PINEVIEW DRIVE AMHERST NY 14228 US 14228


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-03-03

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