DELTON LIGHT CURE PIT AND FISSURE SEALANT 2796

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2013-03-21 for DELTON LIGHT CURE PIT AND FISSURE SEALANT 2796 manufactured by Dentsply Professional.

Event Text Entries

[3325115] In this event it was reported that a patient experienced an allergic reaction to the use of delton, a product used as a sealant. The symptoms reported were swelling of the gingiva which lasted for two weeks. No medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5


[10610173] 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


MAUDE Entry Details

Report Number2515379-2013-00006
MDR Report Key3030606
Report Source00,01
Date Received2013-03-21
Date of Report2013-02-27
Date of Event2013-02-16
Date Mfgr Received2013-02-27
Date Added to Maude2013-04-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactHELEN LEWIS
Manufacturer StreetSUSQUEHANNA COMMERCE CTR. W. 221 W. PHILADELPHIA ST., STE 60
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 NameDELTON LIGHT CURE PIT AND FISSURE SEALANT
Product CodeEBC
Date Received2013-03-21
Catalog Number2796
Lot Number120906
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY PROFESSIONAL
Manufacturer AddressYORK PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.