BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI CURE GI BAND CEMENT

    MDR report key: 1238409 · Received November 19, 2008

    Report

    Report Number
    2020467-2008-00003
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 30, 2008
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS-FOR-USE FOR MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT CONTAIN THE FOLLOWING WARNING: "WARNING: LIQUID CONTAINS HEMA (2-HYDROXYETHYL METHACRYLATE). HEMA IS SEVERELY IRRITATING TO THE EYE AND IS A KNOWN CONTACT ALLERGEN. A SMALL PERCENTAGE OF THE POPULATION IS KNOWN TO HAVE AN ALLERGIC RESPONSE TO ACRYLATE RESINS. TO REDUCE THE RISK OF ALLERGIC RESPONSE, MINIMIZE EXPOSURE TO THESE MATERIALS. IN PARTICULAR, EXPOSURE TO UNCURED RESIN SHOULD BE AVOIDED. USE OF PROTECTIVE GLOVES AND A NO-TOUCH TECHNIQUE IS RECOMMENDED. IF SKIN CONTACTS LIQUID OR POWDER/LIQUID MIX, WASH SKIN IMMEDIATELY WITH SOAP AND WATER. ACRYLATES MAY PENETRATE COMMONLY USED GLOVES. IF GLOVE CONTACTS LIQUID OR POWER/LIQUID MIX, REMOVE AND DISCARD GLOVE, WASH HANDS IMMEDIATELY WITH SOAP AND WATER, AND THEN REGLOVE. LIQUID AND POWDER/LIQUID MIX MAY CAUSE EYE IRRITATION UPON CONTACT AND MAY BE MILDLY IRRITATING TO ORAL SOFT TISSUE UPON CONTACT. AVOID CONTACT WITH EYES AND MINIMIZE CONTACT WITH ORAL SOFT TISSUE. IF CONTACT WITH EYES OCCURS, FLUSH IMMEDIATELY WITH LARGE AMOUNTS OF WATER. IF IRRITATION PERSISTS, CONSULT AT PHYSICIAN."

    Description of Event or Problem · 1

    DURING A REGULAR SCHEDULED ORTHODONTIC APPOINTMENT, AN ADJUSTMENT WAS MADE TO PATIENT'S UPPER ARCHWIRE, AND AN ALGINATE IMPRESSION WAS ALSO DONE IN ORDER TO FABRICATE A LOWER BONDED LINGUAL RETAINER. AFTER ADJUSTING THE UPPER ARCHWIRE, THE HYGIENIST NOTED A LOOSE BAND ON THE PATIENT'S LOWER RIGHT SECOND MOLAR TOOTH. DURING THE PROCEDURE OF CEMENTING THE BAND TO THE PATIENT'S MOLAR WITH MULTI CURE GI BAND CEMENT, PATIENT INDICATED THAT SHE WAS HAVING DIFFICULTY BREATHING AND INFORMED THE ORTHODONTIC STAFF THAT SHE NEEDED HER EPIPEN. PATIENT'S MOTHER ADMINISTERED THE EPIPEN TO PATIENT. AFTER ABOUT 15 MINUTES OF OBSERVATION, PATIENT'S MOTHER TOOK HER TO AN URGENT CARE CLINIC FOR FURTHER OBSERVATION AND EXAMINATION. ORTHODONTIST ADVISED THAT THE PATIENT IS OKAY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI CURE GI BAND CEMENT ORTHODONTIC ADHESIVE DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention ADHESIVE PRIMER| TRANSPALATAL ARCH| EPIPEN| BRACKETS| ETCHING AGENT| ALGINATE IMPRESSION| LIGHT-CURED ADHESIVE| ARCHWIRES| ELASTIC & METAL LIGATURES