BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND SOLO PLUS

    MDR report key: 2042774 · Received April 6, 2011

    Report

    Report Number
    8020994-2011-00001
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K990498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED BY A REPRESENTATIVE AT THE POISON CONTROL CENTER THAT THE PATIENT IS DOING FINE. THE REPRESENTATIVE REFUSED TO PROVIDE FURTHER DETAILS ON THE INCIDENT; HOWEVER, IT WAS STATED THAT THE INCIDENT WAS DUE TO A MISTAKE MADE BY THE DENTIST. NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS IDENTIFIED; THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS ALLEGED BY THE POISON CONTROL CENTER IN (B)(6) THAT A PATIENT EXPERIENCED ACUTE POISONING DURING A PROCEDURE IN WHICH OPTIBOND SOLO PLUS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIBOND SOLO PLUS RESIN TOOTH BONDING AGENT KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R