CHROMACLONE COLORCHANGE B000082

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-20 for CHROMACLONE COLORCHANGE B000082 manufactured by Zhermack S.p.a..

Event Text Entries

[73328958] 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. Retained device was tested and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10


[73328959] It was reported that a patient experienced an allergic reaction after the use of chromaclone color change impression material. The symptoms reported include a rash from his stomach to neck, a sore neck and jaw, warm around the mouth, and shortness of breath. The patient took benadryl for relief.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614794-2017-00001
MDR Report Key6509113
Report SourceDISTRIBUTOR
Date Received2017-04-20
Date of Report2017-04-20
Date of Event2017-01-30
Date Mfgr Received2017-02-03
Date Added to Maude2017-04-20
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 FDA3
Event Location3
Manufacturer ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457551
Manufacturer G1ZHERMACK S.P.A.
Manufacturer StreetVIA BOVAZECCHINO, 100
Manufacturer CityBADIA POLESINE, 45021
Manufacturer CountryIT
Manufacturer Postal Code45021
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHROMACLONE COLORCHANGE
Generic NameMATERIAL, IMPRESSION
Product CodeELW
Date Received2017-04-20
Model NumberNA
Catalog NumberB000082
Lot Number246267
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZHERMACK S.P.A.
Manufacturer AddressVIA BOVAZECCHINO, 100 BADIA POLESINE, 45021 IT 45021


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-20

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