SODIUM HYPOCHLORITE 0011507FG

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 2015-02-06 for SODIUM HYPOCHLORITE 0011507FG manufactured by Dentsply Caulk.

Event Text Entries

[17228253] In this event it was reported that after use of sodium hypochlorite during a root canal therapy procedure, the right side of the pt's face suddenly swelled and the pt was taken to an oral surgeon. The pts' tooth had to be extracted.
Patient Sequence No: 1, Text Type: D, B5


[17455547] The dr thought that the pt may have experienced an allergic reaction to the sodium hypochlorite. However, the symptoms described are more consistent with complications arising from the sodium hypochlorite being extruded beyond the root apex. Due to the permanent loss of the tooth, this event is reportable per 21 cfr part 803. The device is available for eval, though has not been returned as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2515379-2015-00001
MDR Report Key4495744
Report Source05
Date Received2015-02-06
Date of Report2015-01-06
Date of Event2014-05-01
Date Mfgr Received2015-01-06
Date Added to Maude2015-02-10
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 INCSUSQUEHANNA COMMERCE CENTRE W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSODIUM HYPOCHLORITE
Generic NameCLEANSER, ROOT CANAL
Product CodeKJJ
Date Received2015-02-06
Catalog Number0011507FG
Lot Number131218
Device Expiration Date2014-12-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY CAULK
Manufacturer AddressMILFORD DE US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2015-02-06

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