BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCOTCHBOND ETCHANT DELIVERY SYSTEM

    MDR report key: 3012457 · Received March 15, 2013

    Report

    Report Number
    3005174370-2013-00012
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    October 29, 2012
    Report Date
    December 5, 2012
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    KLE
    PMA / PMN Number
    K813180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT CONTAINS 35% PHOSPHORIC ACID TO ETCH THE TOOTH SURFACES DURING USE. INADVERTENT CONTACT WITH SKIN MAY CAUSE A CHEMICAL SKIN BURN AND DEPENDING ON THE NATURE OF THE CONTACT (AREA OF SKIN AND LENGTH OF CONTACT TIME), A SERIOUS BURN CAN OCCUR. IN THIS CASE, IT IS NOT KNOWN TO 3M ESPE WHETHER OR NOT SUCH A BURN OCCURRED. THE IFU AND (B)(6) PROVIDE CAUTIONARY INFO ON THE USE OF THE PRODUCT AND FIRST AID IN CASE OF INADVERTENT CONTACT. THE PRODUCT DOES HAVE A FAVORABLE CLINICAL USE HISTORY WITH ONLY ONE OTHER REPORT OF A SKIN BURN MADE TO 3M ESPE BETWEEN 2008 AND 2012.

    Description of Event or Problem · 1

    TWO FEMALE PTS ((B)(6)) IN (B)(6) WERE REPORTED TO HAVE EXPERIENCED REDNESS AT THE CORNER OF THE MOUTH FOLLOWING A DENTAL PROCEDURE IN WHICH 3M ESPE SCOTCHBOND ETCHANT ON A COTTON ROLL CAME INTO CONTACT WITH THE AREA. BOTH PTS WERE SEEN BY A DERMATOLOGIST, BUT ADD'L INFO WAS NOT MADE AVAILABLE TO THE TREATING DENTIST OR 3M ESPE REGARDING THEIR STATUS.

    Additional Manufacturer Narrative · 2

    THE SUBJECT PRODUCT CONTAINS 35% PHOSPHORIC ACID TO ETCH THE TOOTH SURFACES DURING USE. INADVERTENT CONTACT WITH SKIN MAY CAUSE A CHEMICAL SKIN BURN AND DEPENDING ON THE NATURE OF THE CONTACT (AREA OF SKIN AND LENGTH OF CONTACT TIME), A SERIOUS BURN CAN OCCUR. IN THIS CASE, IT IS NOT KNOWN TO 3M ESPE WHETHER OR NOT SUCH A BURN OCCURRED. THE IFU AND (B)(6) PROVIDE CAUTIONARY INFO ON THE USE OF THE PRODUCT AND FIRST AID IN CASE OF INADVERTENT CONTACT. THE PRODUCT DOES HAVE A FAVORABLE CLINICAL USE HISTORY WITH ONLY ONE OTHER REPORT OF A SKIN BURN MADE TO 3M ESPE BETWEEN 2008 AND 2012.

    Description of Event or Problem · 2

    TWO FEMALE PTS ((B)(6)) IN (B)(6) WERE REPORTED TO HAVE EXPERIENCED REDNESS AT THE CORNER OF THE MOUTH FOLLOWING A DENTAL PROCEDURE IN WHICH 3M ESPE SCOTCHBOND ETCHANT ON A COTTON ROLL CAME INTO CONTACT WITH THE AREA. BOTH PTS WERE SEEN BY A DERMATOLOGIST, BUT ADD'L INFO WAS NOT MADE AVAILABLE TO THE TREATING DENTIST OR 3M ESPE REGARDING THEIR STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110545 SCOTCHBOND ETCHANT DELIVERY SYSTEM ETCHANT KLE 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other
    2 8 YR Other