CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE 607.01.570

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-28 for CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE 607.01.570 manufactured by Dentsply Detrey Gmbh.

Event Text Entries

[128715098] 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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


[128715099] It was reported that a patient experienced an allergic reaction after the use of ceramx universal. Within the first week, the patient had blisters on the palate. The blisters subsided, however the patient has also had a feeling of dry mouth and salivary loss since the use of ceramx, which is still in place.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010638-2018-00012
MDR Report Key8112795
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-11-28
Date of Report2018-11-28
Date Mfgr Received2018-10-29
Date Added to Maude2018-11-28
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 DETREY GMBH
Manufacturer StreetDETREY STRASSE 1
Manufacturer CityKONSTANZ, 78467
Manufacturer CountryGM
Manufacturer Postal Code78467
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE
Generic NameMATERIAL, TOOTH SHADE, RESIN
Product CodeEBF
Date Received2018-11-28
Model NumberNA
Catalog Number607.01.570
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY DETREY GMBH
Manufacturer AddressDETREY STRASSE 1 KONSTANZ, 78467 GM 78467


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-28

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