INTEGRITY TEMPGRIP 666450

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-06 for INTEGRITY TEMPGRIP 666450 manufactured by Dentsply Caulk.

Event Text Entries

[183906217] 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. 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


[183906218] It was reported that a patient experienced a rash after the use of integrity tempgrip. The dentist reported that they had used integrity tempgrip in the past on this patient, and there was never any reaction. The patient is a throat cancer survivor and is currently getting injections for saliva production and is also using chlorohexidine rinse. The dentist also reported that this patient is prone to thrush and that their nightguard was very dirty and causing the patient to have issues. The patient continued with the rinse and the rash is mostly gone.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2515379-2019-00036
MDR Report Key9550244
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-06
Date of Report2020-01-03
Date Mfgr Received2019-12-04
Date Added to Maude2020-01-06
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 FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
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 TEMPGRIP
Generic NameCEMENT, DENTAL
Product CodeEMA
Date Received2020-01-06
Model NumberNA
Catalog Number666450
Lot Number00026736
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY CAULK
Manufacturer Address38 W. CLARK AVE. MILFORD DE 19963 US 19963


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-06

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