BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN EAST TOPICAL ANESTHETIC SKIN REFRIGERANT

    MDR report key: 2230597 · Received August 12, 2011

    Report

    Report Number
    1519179-2011-00001
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 29, 2011
    Report Date
    September 11, 2011
    Manufacturer
    GEBAUER CO.
    Product Code
    MLY
    PMA / PMN Number
    K032671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE SERIOUS NATURE OF THE ADVERSE EVENT, GEBAUER CO IS REPORTING THE EVENT TO THE FDA, BUT DOES NOT BELIEVE IT IS LIKELY THAT GEBAUER'S PAIN EASE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THIS CONCLUSION IS BASED ON THE FOLLOWING: NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED TO GEBAUER SINCE THE INTRODUCTION OF THE PRODUCT IN 2002; THE TWO INGREDIENTS USED IN PAIN EASE ARE COMMONLY USED HALOGENATED HYDROCARBONS AND THE TOXICITY DATA HAS BEEN REVIEWED BY THE U.S. EPA AS WELL AS THE FDA AND NO INSTANCES OF SEIZURES AT DOSING DONE AT HIGH CONCENTRATIONS AND EXTENDED DOSING PERIODS (UP TO TWO YRS) HAVE BEEN REPORTED. TOXICITY STUDIES WERE CONDUCTED FOR BOTH INHALATION AND DERMAL ROUTES OF EXPOSURE; TOXICITY STUDIES PERFORMED BY GEBAUER ON THE PRODUCTS SPECIFIC FORMULATION WERE CONDUCTED AND NO REPORTS OF SEIZURES WERE IDENTIFIED DURING PRODUCT TESTING AND THE SAFETY DATA WAS SUBMITTED DURING THE 510 (K) PROCESS; THE NURSE REPORTED THAT HER PHYSICIAN HAD TAKEN HER OFF OF TRILEPTAL (OXCARBACINE) THE WEEK PRIOR TO THE ADVERSE EVENT. THE MEDICATION GUIDE FOR TRILEPTAL IDENTIFIES THAT SEIZURES CAN OCCUR WHEN THE MEDICATION IS STOPPED; AND THE NURSE EXPERIENCED ANOTHER SEIZURE WHILE AT THE EMERGENCY DEPT AND THERE WAS NO EXPOSURE TO PAIN EASE. MULTIPLE SEIZURES AFTER STOPPING TIRLEPTAL IS ALSO IDENTIFIED IN THE MEDICATION GUIDE FOR THE DRUG AS A POSSIBLE SIDE EFFECT. BASED ON THE SAFETY TESTING CONDUCTED ON THE INGREDIENTS OF GEBAUER'S PAIN EASE, THE NURSE'S MEDICAL HISTORY, AND BEING TAKEN OFF TRILEPTAL SHORTLY BEFORE THE ADVERSE EVENT, IT IS UNLIKELY THAT GEBAUER'S PAIN EASE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    A GEBAUER CO. SALES REP WAS IN-SERVICING A DOCTOR'S OFFICE AND WAS DEMONSTRATING GEBAUER'S PAIN EASE TOPICAL ANESTHETIC SKIN REFRIGERANT. A (B)(6), FEMALE NURSE EXPERIENCED A SEIZURE SHORTLY AFTER BEING SPRAYED TOPICALLY FOR 2 TO 3 SECONDS WITH PAIN EASE. THE SEIZURES LASTED APPROX 2 TO 3 MIN. CPR WAS PERFORMED AND THE NURSE WAS HOSPITALIZED FOR 24 HRS. WHILE IN THE EMERGENCY DEPT, THE NURSE HAD A SECOND SEIZURE. AS REPORTED, THE NURSE RETURNED TO WORK WITHIN A WEEK AND HAD NO IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN EAST TOPICAL ANESTHETIC SKIN REFRIGERANT VAPOCOOLANT MLY GEBAUER CO. 0396-0008-04 9758

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R TEGRETOL (OXCARBAZINE)