HYDRORISE LIGHT BODY NORMAL SET C207000

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 2018-07-13 for HYDRORISE LIGHT BODY NORMAL SET C207000 manufactured by Zhermack S.p.a..

Event Text Entries

[113907725] 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. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[113907726] It was reported that a patient experienced an allergic reaction after the use of hydrorise light body impression material. The symptoms include burning, sloughing and slight inflammation of the patient's lip. It is unknown if the patient required any medical intervention. Additional information has been requested, but is not yet available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614794-2018-00002
MDR Report Key7685392
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-07-13
Date of Report2018-08-27
Date Mfgr Received2018-08-01
Date Added to Maude2018-07-13
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 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 NameHYDRORISE LIGHT BODY NORMAL SET
Generic NameMATERIAL, IMPRESSION
Product CodeELW
Date Received2018-07-13
Model NumberNA
Catalog NumberC207000
Lot Number275761
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2018-07-13

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