BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2163485 · Received June 3, 2011

    Report

    Report Number
    9610902-2011-00010
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    September 11, 2006
    Report Date
    May 31, 2011
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE PT HAD AN ALLERGIC REACTION TO ANY INGREDIENTS. THE GLUMA DESENSITIZER BOTTLE USED, HAD EXPIRED SEPT, 2002. THE INFO FOR USE (IFU) THAT DESCRIBED NECESSARY SAFETY INFO WAS NOT KEPT BY THE DR. NO RUBBER DAM WAS USED AND GLUMA DESENSITIZER CAME IN CONTACT WITH THE GUMS. THE POSSIBLE HAZARD OF SENSITIZATION IS MENTIONED IN THE IFU. IT IS NOT KNOWN IF THE PT HAD ALLERGIES TO THE COMPONENTS OF GLUMA DESENSITIZER (INCLUDING GLUTARALDEHYDE). DUE TO THE TREATMENT WITH SEVERAL DENTAL PRODUCTS THERE WAS NEVER A FINAL PROOF THAT THE PT SHOWED ALLERGIC REACTION TO GLUMA COMPONENTS. THIS REPORT IS BEING SUBMITTED AS A RESULT OF CORRECTIVE MEASURE TO FDA FINDING.

    Description of Event or Problem · 1

    APPROX ONE HOUR BEFORE THE INCIDENT HAPPENED, THE PT HAD RECEIVED A LOCAL ANESTHESIA (ULTRACAIN DS FORTE), SURGIDENT - RETRACTION FILAMENTS WITH ADRENALIN AND A HEMOSTATIC TREATMENT (VISKOSTAT) IN THE DENTAL OFFICE. AN IMPRESSION WAS TAKEN. BEFORE THE DENTIST APPLIED THE PROSTHESIS FOR THE CROWN PREPARATION, GLUMA DESENSITIZER WAS APPLIED, WHICH CAME IN CONTACT WITH THE GUMS. APPROX TWO MINUTES LATER A TINGLING SENSATION AND LATER A SWELLING APPEARED. APPROX TWO MINUTES AFTER APPLICATION OF GLUMA DESENSITIZER THE PT REACTED WITH AN ALLERGIC QUINCKE'S EDEMA ABOVE THE LIP, LATERAL TO THE NOSE, ALONG WITH A SWELLING OF THE EYELID. THE SWELLING WAS IMMEDIATELY COOLED AND A CORTISONE OINTMENT APPLIED. THE SWELLING LASTED FOR FOUR DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 020025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other