BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNITEK MULTICURE BI BAND CEMENT, APC II

    MDR report key: 4338267 · Received December 5, 2014

    Report

    Report Number
    2020467-2014-00002
    Event Type
    Injury
    Date Received
    December 5, 2014
    Date of Event
    September 1, 2014
    Report Date
    November 11, 2014
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    PMA / PMN Number
    K950514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE UNITEK MULTI CURE GLASS IONOMER ORTHODONTIC BAND CEMENT AND THE APC II ADHESIVE-PRECOATED BRACKETS ARE LABELED WITH A WARNING THAT THE PRODUCT CONTAINS ACRYLATES, AND THAT A CERTAIN PERCENTAGE OF THE POPULATION IS KNOWN TO HAVE AN ALLERGIC RESPONSE TO ACRYLATE RESINS.

    Description of Event or Problem · 1

    ON (B)(6) 2014-INSTALLED TWO 3M STAINLESS STEEL MOLAR BANDS USING UNITEK MULTI CURE GLASS IONOMER ORTHODONTIC BAND CEMENT. ALSO INSTALLED A GAC LIP BUMPER; (B)(6) 2014 - INSTALLED UPPER 5X5 3M PREPASTED METAL BRACKETS; (B)(6) 2014 - CHECKED LIP BUMPER, ALL APPEARED OK; (B)(6) 2014 - PATIENT SEEN AT IMMUNOLOGIST FOR DERMATITIS, BLISTERING, REDNESS OF LIPS AND GUMS. PRESCRIBED MOMETASONE, WHICH SEEMED TO HELP; (B)(6) 2014 - PATIENT RETURNED TO ORTHODONTIST AND ALL COMPONENTS WERE REMOVED. MULTIPLE ITEMS PREPARED FOR PATCH TESTING; (B)(6) 2014 - EVALUATION PREPARED BY IMMUNOLOGIST. FINDINGS/SUSPICIONS SOMEWHAT PRELIMINARY WITH POSSIBLE CROSS CONTAMINATION IN INITIAL PATCH TESTS. REACTIONS WERE CITED TO PIECES OF THE LIP BUMPER NYLON, THE LIP BUMPER WIRE, A GRAY BAND TIE, AND A SAMPLE OF A 3M ADHESIVE SIMILAR TO THAT ON THE PREPASTED BRACKET. THE PREPASTED BRACKET WAS NOT SUBMITTED FOR PATCH TESTING. THE DOCTOR'S INITIAL OPINION WAS THAT THE PATIENT DEVELOPED A SENSITIVITY TO METHACRYLATE OVER TIME AND THAT THE NON-ADHESIVE SAMPLES MAY HAVE HAD A RESIDUE OT THE INITIAL GI BAND CEMENT OR APC II BRACKET ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786160 UNITEK MULTICURE BI BAND CEMENT, APC II ADHESIVE, BRACKET/TOOTH COND, RESIN DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention 3M APC II METAL BRACKETS, UNK MFR ARCHWIRE| GAC LIP BUMPER, UNK MFR GRAY BAND TIE,| 3M MOLAR BANDS,