BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2135162 · Received June 3, 2011

    Report

    Report Number
    9610902-2011-00009
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    July 24, 2008
    Report Date
    May 31, 2011
    Manufacturer
    HERAEUS KULZER, HMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    HYPERTENSION HAS NOT BEEN DESCRIBED AS A SIDE EFFECT TO DATE, BUT DIZZINESS IS A KNOWN SIDE EFFECT. WITH ALL WE KNOW ABOUT GLUTARALDEHYDE AND GLUMA DESENSITIZER, WE DO NOT SEE A DIRECT EFFECT CONNECTION BETWEEN GLUMA DESENSITIZER AND THE SYMPTOMS OF THE PT. POSSIBLE REASON FOR THE SITUATION INCLUDE THE PT'S ADVANCED AGE, A POSSIBLE FEAR OF THE DENTAL TREATMENT, THE TREATMENT OF HYPERSENSITIVE CERVICAL AREAS FOR THE ACUPUNCTURE. THE SMELL IN CONNECTION WITH BREATHING DIFFICULTIES AND RESULT IN THE CONDITION OF HYPERTENSION WITHOUT ANY DIRECT CHEMICAL EFFECT. WE CANNOT EXCLUDE THE CONNECTION BETWEEN GLUMA DESENSITIZER AND THE SYMPTOMS OF POTENTIAL INTERACTION BETWEEN GLUMA DESENSITIZER AND OTHER MEDICINE THAT PT MAY HAVE BEEN TAKING, OR THE STATE OF MIND DUE TO THE STRESSFUL SITUATION OF THE PT. THIS REPORT IS BEING SUBMITTED AS A RESULT OF CORRECTIVE MEASURE TO FDA FINDING.

    Description of Event or Problem · 1

    THE PT COMPLAINED DURING OR AFTER A TREATMENT, DUE TO HYPERSENSITIVE CERVICAL AREAS ABOUT HYPERTENSION. THE CONDITION LASTED FOR ONE HOUR AND THE NOTIFYING DENTIST CLASSIFIED THE SIDE EFFECT AS LIFE-THREATENING. DUE TO THE HYPERTENSION, THE PT WAS REFERRED TO THE GENERAL PRACTITIONER WITH SUSPECTED ALLERGIC REACTION, ALTHOUGH NO ALLERGIES WERE KNOWN. THE PT FULLY RECOVERED WITHOUT LINGERING SIDE EFFECTS. FURTHERMORE, THE PT SUBMITTED TO AN ACUPUNCTURE TREATMENT. THE REPORT DOES NOT INDICATE IF THE NOTIFYING DENTIST PERFORMED THIS BEFORE OR DURING THE TREATMENT TO REDUCE THE FEAR AND POTENTIAL PAIN, OR IF THE ACUPUNCTURE WAS DONE FOR THE TREATMENT OF THE HYPERTENSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other