BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER

    MDR report key: 6063428 · Received October 28, 2016

    Report

    Report Number
    3009443653-2016-00033
    Event Type
    Injury
    Date Received
    October 28, 2016
    Report Date
    September 29, 2016
    Manufacturer
    VALEANT PHARMACEUTICALS INTERNATIONAL
    Product Code
    JCC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716396 ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER PH BUFFER JCC VALEANT PHARMACEUTICALS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other