BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ESPE ADPER SINGLE BOND 2

    MDR report key: 2572357 · Received May 8, 2012

    Report

    Report Number
    3005174370-2012-00011
    Event Type
    Injury
    Date Received
    May 8, 2012
    Report Date
    April 26, 2012
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    KLE
    PMA / PMN Number
    K962785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO MFR REPORT NUMBER 3005174370-2012-00010 FOR FILTEK Z250 UNIVERSAL RESTORATIVE WHICH WAS ALSO USED IN THIS EVENT. BOTH FILTEK Z250 UNIVERSAL RESTORATIVE AND ADPER SINGLE BOND 2 (ALSO SOLD AS ADPER SINGLE BOND PLUS AND SCOTCHBOND 1XT IN OTHER REGIONS OF THE WORLD) HAVE A HIGHLY FAVORABLE CLINICAL USAGE HISTORY AND NO OTHER REPORTS OF ANAPHYLAXIS HAVE BEEN MADE TO 3M ESPE IN THE OVER 5 YEARS OF HISTORY REVIEWED. IN THIS SAME TIME FRAME, IT IS ESTIMATED THAT OVER (B)(4) CLINICAL APPLICATIONS OF FILTEK Z250 AND OVER (B)(4) CLINICAL APPLICATIONS OF ADPER SINGLE BOND 2/ADPER SINGLE BOND PLUS/SCOTCHBOND 1XT HAVE BEEN MADE. THE 3M ESPE HAS ALSO THOROUGHLY REVIEWED THE BIOCOMPATIBILITY OF BOTH PRODUCTS USING CURRENT NATIONAL GUIDANCE DOCUMENTS AND INTERNATIONAL STANDARDS ON MEDICAL AND DENTAL DEVICE SAFETY. IN OUR ASSESSMENT, WHICH WAS CONDUCTED BY A BOARD-CERTIFIED TOXICOLOGIST, NO POTENTIAL FOR EITHER PRODUCT TO CAUSE AN ANAPHYLACTIC REACTION WAS IDENTIFIED AND THE CONCLUSION OF THE ASSESSMENT WAS THAT BOTH PRODUCTS ARE SAFE FOR THEIR INTENDED USE.

    Description of Event or Problem · 1

    IT WAS LEARNED BY 3M ESPE ((B)(4)) THAT A (B)(6) BOY WAS HAVING A CAVITY FILLED WITH 3M ESPE FILTEK Z250 UNIVERSAL RESTORATIVE, WITH 3M ESPE ADPER SINGLE BOND 2 USED AS THE DENTAL ADHESIVE. AS THE MATERIALS WERE BEING PLACED, THE DENTIST NOTICED SWELLING OF THE CHILD'S THROAT AND SENT THE PT WITH PARENT TO AN EMERGENCY ROOM FOR TREATMENT WITH AN ORAL MEDICATION (FURTHER DETAILS ON NATURE OF MEDICATION ADMINISTERED WERE NOT MADE AVAILABLE TO 3M ESPE). THE BOY WAS REPORTED TO HAVE MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ESPE ADPER SINGLE BOND 2 RESIN TOOTH BONDING AGENT KLE 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention