BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIKE 4OZ LIQUID

    MDR report key: 6605730 · Received June 1, 2017

    Report

    Report Number
    1410097-2017-00001
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    March 7, 2017
    Report Date
    June 1, 2017
    Manufacturer
    GC AMERICA INC.
    Product Code
    EBG
    UDI-DI
    D6583405911
    PMA / PMN Number
    K833261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UNABLE TO REACH PATIENT OR DENTIST.

    Description of Event or Problem · 1

    GC AMERICA INC. (GCA) RECEIVED A LETTER FROM A PATIENT ON 17 MAR 2017. THE PATIENT HAD RECEIVED DENTAL WORK IN A UNIVERSITY SETTING BY A DENTAL PROVIDER ON 07 MAR 2017. THE PATIENT'S MOUTH BEGAN TO BURN. THE DENTAL PROVIDER HAD USED THE FOLLOWING CHEMICALS: VISCOSTAT, HENRY SCHEIN TEMPORARY CEMENT REMOVER, VPS TRAY ADHESIVE, AND ALIKE LIQUID MONOMER. THE DENTAL PROVIDER PUT VASELINE ON THE PATIENT'S BURNED LIPS AND GAVE THE PATIENT VASELINE TO CONTINUE PUTTING ON THEIR MOUTH. ON (B)(6) 2017, THE PATIENT HAD AN APPOINTMENT WITH THEIR PERSONAL DOCTOR TO EXAMINE THE BURNS AND TO CHECK THEIR HIGH BLOOD PRESSURE. THE PERSONAL DOCTOR PRESCRIBED CEPHALEXIN TO PREVENT AN INFECTION FROM THE BURNS AND SILVER SULFADIAZINE TO AVOID OR TREAT SKIN INFECTIONS FROM THE BURNS. NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386667 ALIKE 4OZ LIQUID TEMPORARY CROWN AND BRIDGE RESIN EBG GC AMERICA INC. D6583405911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TEMPORARY CEMENT REMOVER (HENRY SCHEIN)| VISCOSTAT| VPS TRAY ADHESIVE