NUPRO EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE 801600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-22 for NUPRO EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE 801600 manufactured by Dentsply Professional.

Event Text Entries

[48000492] 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. This report is for the first patient. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[48000493] It was reported that two patient's experienced an allergic reaction following treatment with nupro extra care polish spearmint. In the first patient, they reported a sore throat and that their cheeks were feeling like they were stuck to their teeth. No medical treatment was needed. The symptoms were still present several weeks after treatment.
Patient Sequence No: 1, Text Type: D, B5


[55164887] Multiple unsuccessful attempts were made to obtain the device for evaluation. Retain product was tested and found to be within specification. Also, a dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2424472-2016-00048
MDR Report Key5743269
Date Received2016-06-22
Date of Report2016-05-26
Date of Event2016-05-03
Date Mfgr Received2016-08-22
Date Added to Maude2016-06-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 G1DENTSPLY CAULK
Manufacturer Street38 W. 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 EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE
Generic NameAGENT, POLISHING, ABRASIVE, ORAL CAVITY
Product CodeEJR
Date Received2016-06-22
Model NumberNA
Catalog Number801600
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY PROFESSIONAL
Manufacturer Address1301 SMILE WAY YORK PA 17404 US 17404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-06-22

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