AH PLUS ROOT CANAL SEALER 60620112

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-12-09 for AH PLUS ROOT CANAL SEALER 60620112 manufactured by Dentsply Detrey Gmbh.

Event Text Entries

[62076323] 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. Retention product was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10


[62076324] It was reported that a patient experienced swelling of their cheek after a root canal filling with ah plus sealer. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010638-2016-00008
MDR Report Key6164974
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2016-12-09
Date of Report2016-12-09
Date Mfgr Received2016-11-11
Date Added to Maude2016-12-09
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 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 DETREY GMBH
Manufacturer StreetDETREY STRASSE 1
Manufacturer CityKONSTANZ, 78467
Manufacturer CountryGM
Manufacturer Postal Code78467
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAH PLUS ROOT CANAL SEALER
Generic NameRESIN, ROOT CANAL FILLING
Product CodeKIF
Date Received2016-12-09
Model NumberNA
Catalog Number60620112
Lot Number1602000162
Device Expiration Date2017-11-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY DETREY GMBH
Manufacturer AddressDETREY STRASSE 1 KONSTANZ, 78467 GM 78467


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-12-09

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