NUPRO PROPHY PASTE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-10 for NUPRO PROPHY PASTE UNK manufactured by Dentsply Professional.

Event Text Entries

[5645612] In this event it was reported that a pediatric pt experienced an allergic reaction after a dental procedure that included the use of nupro prophy paste. The reported symptoms included itching and watery eyes. The pt was treated with cortisone and antihistamines. All symptoms disappeared after treatment was stopped.
Patient Sequence No: 1, Text Type: D, B5


[13189799] While it is unk if the device used in this case caused or contributed to the pt'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 eval, though has not been returned as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2424472-2015-00016
MDR Report Key4694059
Report Source01,05
Date Received2015-04-10
Date of Report2015-03-13
Date Mfgr Received2015-03-13
Date Added to Maude2015-04-16
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 FDA0
Event Location0
Manufacturer ContactHELEN LEWIS
Manufacturer Street221 W PHILADELPHIA ST, STE 60
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUPRO PROPHY PASTE
Generic NameORAL CAVITY ABRASIVE POLISHING AGENT
Product CodeEJR
Date Received2015-04-10
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY PROFESSIONAL
Manufacturer AddressYORK PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-04-10

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