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 2016-10-28 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.

Event Text Entries

[58654972] The product is not available for return and the lot number was not reported. An assessment of the event was completed by valeant medical personnel. The event is possibly related to the product but could also be by vasoconstriction from epinephrine in a pdl injection. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10


[58654973] A dentist reported when he used the pen alongside a wand, the patient experienced tissue necrosis. It was a single tooth anesthesia pdl with wand technique. The pen was dialed to either 18 or 9 and lidocaine was used as a buffer. He states they would sometimes use dental vibes with the onset and wand. It is unknown if the patient experienced the necrosis immediately or after a couple days. There is no sign of infection. No medical intervention was necessary but the dentist states that it takes time to heal and may be up to a year before the tissues grow back. This report is for patient 5.
Patient Sequence No: 1, Text Type: D, B5


[61907790] 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


MAUDE Entry Details

Report Number3009443653-2016-00035
MDR Report Key6063452
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-10-28
Date of Report2016-09-29
Date Mfgr Received2016-11-08
Date Added to Maude2016-10-28
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 Received2016-10-28
ID NumberNI
OperatorDENTIST
Device AvailabilityN
Device AgeDA
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 2016-10-28

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