CERCON CERAM KISS GLAZE 67163503

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-22 for CERCON CERAM KISS GLAZE 67163503 manufactured by Dentsply Prosthetics.

Event Text Entries

[19176373] It was reported that a patient developed swelling of the lips and gums with an itching sensation after use of a prosthetic fashioned using cercon ceram kiss glaze. The patient sought treatment from an allergy specialist and was determined to be allergic to cobalt, chromium, and cobalt dichloride (none of which are components of the kiss glaze); the exact treatment administered, if any, is unknown as of this report.
Patient Sequence No: 1, Text Type: D, B5


[19327194] 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. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review. Further information pertaining to outcome of this event will be reported if it becomes available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9681199-2008-00006
MDR Report Key1001071
Report Source05
Date Received2008-02-22
Date of Report2008-01-25
Date of Event2008-01-24
Date Mfgr Received2008-01-25
Date Added to Maude2008-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactHELEN LEWIS
Manufacturer StreetSUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST. STE. 60
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Manufacturer G1DEGUDENT GMBH
Manufacturer StreetRODENBACHER CHAUSSEE 4
Manufacturer CityHANAU/WOLFGANG D-63457
Manufacturer CountryGM
Manufacturer Postal CodeD-63457
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERCON CERAM KISS GLAZE
Product CodeEIH
Date Received2008-02-22
Model NumberNA
Catalog Number67163503
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key970175
ManufacturerDENTSPLY PROSTHETICS
Manufacturer AddressYORK PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-02-22

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