BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOOTH-N-SEAL LIQUID PROTECTANT

    MDR report key: 579355 · Received March 3, 2005

    Report

    Report Number
    1034548-2005-00006
    Event Type
    Other
    Date Received
    March 3, 2005
    Date of Event
    November 12, 2004
    Report Date
    March 3, 2005
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MZW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER DID NOT REALIZE THAT PRODUCT WOULD FORM A "LIKE A GLUE" OVER THE SORE IN THEIR MOUTH. USER APPLIED THE ADHESIVE AND AFTER ABOUT TEN MINUTES IT FELT UNCOMFORTABLE AND USER TRIED TO REMOVE THE ADHESIVE FROM THEIR MOUTH USING THEIR TEETH TO PRY THE ADHESIVE OFF AND THEIR TOOTH BROKE OFF. USER DID NOT REALLY KNOW, HOW THE PRODUCT WORKS, THAT IT WOULD FORM A SEAL OVER THE SORE. USER COULD NOT EAT OR DRINK WITH THE ADHESIVE IN PLACE. USER LAST WENT TO DENTIST MAYBE A YEAR AGO BUT INSISTS THERE IS NOTHING WRONG WITH THEIR TEETH. DENTIST STATES THAT THE DAMAGE TO THE TOOTH IS TOO CLOSE TO THE NERVE TO CORRECT AS HE NORMALLY WOULD, HE HAD TO DO IT ANOTHER WAY. DENTIST STATES THAT WHEN THE USER PRIED THE ADHESIVE OFF HIS TOOTH. USER FRACTURED THE DISTAL OCCLUSAL SURFACE TO TOOTH # 19. THE DENTIST REPORTS THAT WHEN HE SAW THE USER THERE WAS A FRACTURE OF THE DOL CUSP WITH ACTIVE DECAY PRESENT. THE DECAY WAS REMOVED, THE FRACTURED CUSP ALLEVIATED, AN INDIRECT CAP WAS PLACED DUE TO THE CLOSE PROXIMITY TO THE NERVE, AND A COMPOSITE RESTORATION WAS CHOOSEN TO HELP HOLD THE TOOTH TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOOTH-N-SEAL LIQUID PROTECTANT LIQUID PROTECTANT FOR CANKER SORE PAIN RELIEF MZW CLOSURE MEDICAL CORP. NA 054130

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other