BEUDAMED
    FDA Adverse Event Summary report: N

    HYDENT ARTICULATION PASTE

    MDR report key: 4929870 · Received July 21, 2015

    Report

    Report Number
    3011632-2015-00001
    Date Received
    July 21, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 21, 2015
    Manufacturer
    PASCAL COMPANY, INC.
    Product Code
    EFH
    PMA / PMN Number
    K911259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, PASCAL RECEIVED A CALL FROM THE SPOUSE OF PATIENT WHO EXPERIENCED SYMPTOMS COMMONLY ASSOCIATED WITH A HEART ATTACK APPROXIMATELY 1 HOUR AFTER UNDERGOING A DENTURE FITTING ON (B)(6) DURING WHICH HYDENT, PASCAL'S OCCUSAL SPRAY WAS USED. THE SYMPTOMS INCLUDED PAIN IN LOWER RIB CAGE, SHORTNESS OF BREATH, COLD SWEAT, DRY HEAVES, TIGHTENING OF CHEST. THE PURPOSE OF THE CALL WAS TO DISCOVER THE INGREDIENTS OF HYDENT TO DETERMINE IF ANY COMPONENT MAY HAVE CONTRIBUTED TO THE SYMPTOMS. BECAUSE PATIENT WEARS A PACEMAKER, HE WENT TO THE EMERGENCY ROOM, WHERE DOCTORS DETERMINED HE DID NOT EXPERIENCE A HEART ATTACK AFTER PERFORMING A VARIETY OF TESTS, INCLUDING AN EKG. THE ER PHYSICIAN ADMINISTERED LOW-DOSE ASPIRIN AND NITROGLYCERIN. HE WAS DISCHARGED AND THE SYMPTOMS SUBSIDED ABOUT 1 HOUR AFTER LEAVING HOSPITAL. THE SPOUSE INDICATED THAT THE PATIENT WAS ALLERGIC TO TOPICAL ANALGESICS. I ASKED THE DENTIST IF THEY APPLIED ANY TOPICAL GELS, AND SHE SAID THEY DID NOT. THE DENTIST INDICATED THAT THE PATIENT SEEMED AGITATED UPON ARRIVAL TO THE CLINIC, AND BECAME MORE SO WHEN TOLD HE HAD TO SIT IN THE DENTAL CHAIR FOR THE FITTING. THE DENTIST STATED THAT THE PATIENT WANTED TO REMAIN STANDING DURING THE FITTING. NO REASON WAS GIVEN BY THE PATIENT. ON (B)(6) THE RESULTS OF A STRESS TEST WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471743 HYDENT ARTICULATION PASTE DENTURE ARTICULATION AEROSOL PASTE EFH PASCAL COMPANY, INC. N/A 050117

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other