BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND

    MDR report key: 92574 · Received May 22, 1997

    Report

    Report Number
    MW4001879
    Event Type
    Injury
    Date Received
    May 22, 1997
    Report Date
    May 7, 1997
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT'S DENTIST USED THE PRODUCT, INTENDED TO TREAT SENSITIVE GUMS, ON HER 4 TIMES DURING A SIX-MONTH PERIOD. THE PRODUCT BURNED HER GUMS SEVERELY, AND CAUSED A GREAT DEAL OF PAIN. THE DENTIST CLAIMS NEVER TO HAVE SEEN THIS REACTION BEFORE BUT CONTINUED TO USE THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIBOND SENSITIVE GUM TREATMENT KLE KERR DENTAL MATERIALS CENTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *