BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER

    MDR report key: 6158639 · Received December 9, 2016

    Report

    Report Number
    3009443653-2016-00044
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    VALEANT PHARMACEUTICALS INTERNATIONAL
    Product Code
    JCC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813896 ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER PH BUFFER JCC VALEANT PHARMACEUTICALS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other