BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-CURE GLASS IONOMER BAND CEMENT

    MDR report key: 517968 · Received March 26, 2004

    Report

    Report Number
    2020467-2004-00004
    Event Type
    Injury
    Date Received
    March 26, 2004
    Date of Event
    March 13, 2004
    Report Date
    March 16, 2004
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REGISTERED DENTAL ASSISTANT (RDA) REPORTED THAT PATIENT HAD A REACTION CONSISTENT WITH CONTACT DERMATITIS AFTER A BAND WAS RE-CEMENTED ON PT'S TOOTH. RDA REPORTED THAT AT THE BEGINNING OF PATIENT'S ORTHODONTIC TREATMENT, PATIENT EXPERIENCED MILD IRRITAION WHEN THE BANDS WERE INITIALLY CEMENTED ON THEIR TEETH. SUBSEQUENTLY, ON TWO SEPARATE OCCASIONS WHEN A BAND HAD TO BE RE-CEMENTED, PATIENT EXPERIENCED INCREASED DERMATITIS WITH EACH OCCASION. IN 2004, WHEN PATIENT HAD ANOTHER BAND RE-CEMENTED, THEY EXPERIENCED A RED, INFLAMED A RASH AND PUFFY LIPS. ORTHODONTIST REMOVED THE BAND AND PATIENT'S PEDIATRICIAN PRESCRIBED A STERIOD (PREDNISONE) FOR REACTION. PATIENT HAS COMPLETELY RECOVERED FROM THE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-CURE GLASS IONOMER BAND CEMENT ORTHODONTC BAND CEMENT DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention ARCHWIRES THERAPY DATES: 2003 TO PRESENT.| ORTHODONTIC BRACKETS, BANDS, BUCCAL TUBES,