INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM 666220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-11 for INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM 666220 manufactured by Dentsply Caulk.

Event Text Entries

[31006346] While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the first patient. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[31006347] In this event it was reported that four patients experienced adverse reactions after use of integrity c&b material. In all of the cases, the oral tissue was red, inflamed and ulcerated. The patients were treated with cholorhexodine for the inflammation. One of the patients was reported to have an allergy to sulfa.
Patient Sequence No: 1, Text Type: D, B5


[39256361] The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2515379-2015-00067
MDR Report Key5217417
Date Received2015-11-11
Date of Report2015-10-12
Date Mfgr Received2016-01-25
Date Added to Maude2015-11-11
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 FDA3
Event Location3
Manufacturer ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
Manufacturer G1DENTSPLY CAULK
Manufacturer Street38 W. CLARK AVE.
Manufacturer CityMILFORD DE 19963
Manufacturer CountryUS
Manufacturer Postal Code19963
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM
Generic NameCROWN AND BRIDGE, TEMPORARY, RESIN
Product CodeEBG
Date Received2015-11-11
Model NumberNA
Catalog Number666220
Lot Number150612
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY CAULK
Manufacturer Address38 W. CLARK AVE. MILFORD DE 19963 US 19963


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-11-11

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