BEUDAMED
    FDA Adverse Event Summary report: N

    SCOTCHBOND UNIVERSAL ETCHANT

    MDR report key: 3049516 · Received April 4, 2013

    Report

    Report Number
    9611385-2013-00006
    Date Received
    April 4, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    EJK
    PMA / PMN Number
    K810266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT REMAINS UNCLEAR HOW THE TIP OF THE SYRINGE CAME OFF ALLOWING ETCHANT TO SPILL IN THE PATIENT'S EYE; DENTAL OFFICE IS UNWILLING, AT THIS TIME, TO RETURN THE COMPLAINT SAMPLE FOR EVALUATION BY 3M ESPE. THE GLOBAL CLINICAL COMPLAINT HISTORY FOR THE SUBJECT PRODUCT IS FAVORABLE. THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE REPORTED, INCLUDING NO REPORTS OF THE ETCHANT SYRINGE TIP COMING OFF BEFORE OR DURING USE.

    Description of Event or Problem · 1

    (B)(6) PATIENT EXPERIENCED A BURN IN THE EYE AFTER AN INCIDENTAL EXPOSURE TO 3M (TM) ESPE (TM) SCOTCHBOND (TM) UNIVERSAL ETCHANT. DENTAL OFFICE REPORTED THEY TESTED THE SUBJECT PRODUCT BEFORE THE PROCEDURE AND IT WAS WORKING PROPERLY; HOWEVER, THE SYRINGE TIP CAME OFF AND ETCHANT SPILLED IN PATIENT'S EYE. THE DENTAL PROFESSIONALS IMMEDIATELY FLUSHED THE EYE, AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR FURTHER TREATMENT. THE PATIENT RECEIVED ANOTHER EYE FLUSH AT THE ER AND WAS PRESCRIBED EYE SALVE TO BE APPLIED EVERY 2 HOURS. THE PATIENT WAS SEEN AT THE HOSPITAL FOR FOLLOW-UP THE FOLLOWING DAY ((B)(6)) WHERE IT WAS RECOMMENDED THAT SALVE BE APPLIED EVERY HOUR AND TO RETURN ON (B)(6) FOR ANOTHER EVALUATION. THE MOTHER OF THE PATIENT REPORTED THAT THE DIAGNOSIS IS A BURN IN THE EYE. THE DENTAL OFFICE HAS MADE SEVERAL ATTEMPTS TO FOLLOW-UP FOR CURRENT PATIENT STATUS; NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137532 SCOTCHBOND UNIVERSAL ETCHANT ETCHING GEL EJK 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention