NUPRO PROPHY PASTE 801309

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 2013-07-31 for NUPRO PROPHY PASTE 801309 manufactured by Dentsply Professional.

Event Text Entries

[3641853] In this event, it was reported that after a pt with multiple allergies completed a prophylaxis cleaning with nupro prophy paste, her lips began to swell. After leaving the dentist office, she became itchy and noticed hives. The pt went to urgent care and received a spectrum/benadryl shot. Her symptoms abated within a half hour.
Patient Sequence No: 1, Text Type: D, B5


[10937047] 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 was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2515379-2013-00034
MDR Report Key3280990
Report Source05
Date Received2013-07-31
Date of Report2013-07-02
Date Mfgr Received2013-07-02
Date Added to Maude2013-08-13
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 FDA0
Event Location0
Manufacturer ContactHELEN LEWIS
Manufacturer Street221 W PHILADELPHIA ST SUSQUEHANNA COMMERCE CENTER W, STE 60
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Manufacturer G1DENTSPLY CAULK
Manufacturer Street38 WEST CLARKE 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 Received2013-07-31
Returned To Mfg2013-07-16
Catalog Number801309
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY PROFESSIONAL
Manufacturer AddressYORK PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-07-31

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