ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-09 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.

Event Text Entries

[61895206] An assessment of the event was performed by valeant medical personnel. The event is possibly related to the product. The product was not returned and the lot number was not reported. The manufacturer's investigation identified no causal factors and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10


[61895207] Doctor reported a male patient experienced tissue necrosis after using lidocaine buffered with onset dialed to 17 for a pdl injection. Patient is a smoker. The doctor uses onset regularly in non-smokers with no issue. The patient experienced tissue sloughing one week after dental treatment. The event was fully resolved 1. 5 months later with no intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009443653-2016-00044
MDR Report Key6158639
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-12-09
Date of Report2016-11-09
Date Mfgr Received2016-11-09
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 ContactMS. SHARON SPENCER
Manufacturer Street50 TECHNOLOGY DRIVE WEST
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9493985698
Manufacturer G1ALLIANCE MEDICAL PRODUCTS, A SIEGFRIED COMPANY
Manufacturer Street9342 JERONIMO ROAD
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER
Generic NamePH BUFFER
Product CodeJCC
Date Received2016-12-09
ID NumberNI
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVALEANT PHARMACEUTICALS INTERNATIONAL
Manufacturer AddressROCHESTER NY 14609 US 14609


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-12-09

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