BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUDE ARTICULATION SPRAY

    MDR report key: 2588148 · Received May 22, 2012

    Report

    Report Number
    3011632-2012-00002
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    February 9, 2012
    Report Date
    May 21, 2012
    Manufacturer
    PASCAL CO., INC.
    Product Code
    EFH
    PMA / PMN Number
    K912632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT CONTACTED OUR OFFICE REPORTING AN ADVERSE REACTION TO OUR PRODUCT, OCCLUDE ARTICULATION SPRAY. SYMPTOMS INCLUDED COUGH AND TICKLE IN THE THROAT AT THE TIE OF THE DENTAL PROCEDURE. DURING THE COURSE OF THE FOLLOWING FEW WEEKS SINCE THE DATE OF EVENT THE PT EXPERIENCED DISORIENTATION, LOSS OF APPETITE, SWELLING OF AIRWAY, DIFFICULTY BREATHING, CHEST PAINS, SWOLLEN LIVER, AND HYPERTHYROIDISM. THE PT WAS REQUESTING A LIST OF INGREDIENTS TO DETERMINE WHAT, IF ANY, COULD HAVE CAUSED THESE SYMPTOMS. THE PT WENT TO THE HOSPITAL EMERGENCY ROOM. IT WAS UNCLEAR FROM THE PT WHAT TREATMENT SHE RECEIVED, OR THE FULL EXTENT OF ANY TESTS PERFORMED. ONE TEST THAT SHE SAID WAS PERFORMED WAS FOR LIVER ENZYMES, WHICH WERE REPORTED TO BE VERY HIGH. THE PT REFUSED TO SUPPLY THE NAME OF THE DENTIST OR THE CLINIC. SHE STATED THAT SHE WANTED TO WAIT UNTIL THE DENTIST COMPLETED THE PROCEDURE BEFORE HE BECAME INFORMED OF HER INQUIRIES. THE PT SOUGHT MEDICAL ATTENTION AFTER THE EMERGENCY VISIT. THE PHYSICIAN INFORMED HER THAT SHE HAD BEEN "POISONED" AND REQUIRED DETOXIFICATION MEASURES. THE PHYSICIAN ADMINISTERED AN INTRAVENOUS VITAMIN C AND GLUTATHIONE OVER THE COURSE OF SEVERAL WEEKS. ON (B)(6), THE PT PROVIDED THE NAME OF THE DENTIST. I CONTACTED THE CLINIC AND WAS TOLD BY THE REP THAT THE PT GAVE EXPRESSED INSTRUCTIONS NOT TO DIVULGE ANY INFO; THAT THE PT WANTED TO BE THE SOLE PROVIDER OF INFO. THE REP INFORMED ME THAT THE CLINIC GAVE THE PT THE UNIT OF OCCLUDE FOR HER TO CONDUCT ALLERGY TESTS. I CONTACTED THE PT REQUESTING THE LOT NUMBER, BUT WAS UNSUCCESSFUL IN OBTAINING IT. THE CLINIC SAID THAT THE PT HAD PROVIDED THE CLINIC A LIST OF APPROVED DRUGS FOR ANY PROCEDURES. THE PT SAID THAT SHE WAS ALLERGIC TO CERTAIN DYES, AND HAS A GENERAL SENSITIVITY TO MANY CHEMICALS. SHE SAID THAT SHE SUSPECTED THE PROPELLANT, ISOBUTANE, WAS THE CAUSE OF HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUDE ARTICULATION SPRAY DENTAL ARTICULATION SPRAY EFH PASCAL CO., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization