NUPRO PROPHY PASTE 80132701

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 2013-05-20 for NUPRO PROPHY PASTE 80132701 manufactured by Dentsply Professional.

Event Text Entries

[3529178] In this event it was reported that a patient developed a rash on their tongue and a "lump in throat" after a treatment procedure using nupro prophy paste. The patient was administered zyrtec and the symptoms abated after 1 hour.
Patient Sequence No: 1, Text Type: D, B5


[10787545] 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 is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2515379-2013-00023
MDR Report Key3139829
Report Source05
Date Received2013-05-20
Date of Report2013-04-25
Date of Event2013-04-25
Date Mfgr Received2013-04-25
Date Added to Maude2013-06-03
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 SUSQUEHANNA COMMERCE CENTER W.
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Manufacturer G1DENTSPLY CAULK
Manufacturer Street38 WEST CLARK AVE.
Manufacturer CityMILFORD DE 19963
Manufacturer CountryUS
Manufacturer Postal Code19963
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUPRO PROPHY PASTE
Product CodeEJR
Date Received2013-05-20
Returned To Mfg2013-05-15
Catalog Number80132701
Lot Number10090201
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY PROFESSIONAL
Manufacturer AddressYORK PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-05-20

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