BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN EASE

    MDR report key: 4117372 · Received September 19, 2014

    Report

    Report Number
    1519179-2014-00001
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GEBAUER CO.
    Product Code
    MLY
    PMA / PMN Number
    K032671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELEVATION OF THE COMPLAINT IDENTIFIES THAT THE PT MOST LIKELY EXPERIENCED AN ALLERGIC REACTION TO THE PRODUCT OR THE AEROSOL DELIVERY SYSTEM OF THE PRODUCT TRIGGERED AN ASTHMATIC REACTION. THESE WOULD NOT TYPICALLY BE CONSIDERED SERIOUS ILLNESSES BUT SINCE MEDICAL INTERVENTION, BENADRYL, WAS PROVIDED TO THE PT, GEBAUER TREATS THE ADVERSE EVENT AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    PT HAD MEDICAL DEVICE (TOPICAL ANESTHETIC SKIN REFRIGERANT) APPLIED TO HER ARM PRIOR TO AN IV START IN PREPARATION FOR A SURGICAL PROCEDURE. AFTER APPLICATION OF THE DEVICE SHE EXPERIENCED NASAL TINGLING, COUGHING AND CHEST HEAVINESS. THE HOSPITAL ADMINISTERED BENADRYL WHICH ALLEVIATED HER SYMPTOMS AND AFTER APPROXIMATELY 30 MINUTES THE HOSPITAL PERFORMED SURGICAL PROCEDURE AS PLANNED. PT IDENTIFIED AT THE TIME OF REPORT SHE HAD NO FURTHER SYMPTOMS. PT HAD NEVER BEEN EXPOSED TO PRODUCT PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583670 PAIN EASE MLY GEBAUER CO. 0386-008-03

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SALINE SOLUTION VIA IV