BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROSTBITE

    MDR report key: 8957915 · Received September 3, 2019

    Report

    Report Number
    1419341-2019-00004
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 5, 2019
    Report Date
    February 21, 2020
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    THE REPORTER CALLED TO REPORT AN ADVERSE EVENT THAT THEY ASSOCIATED WITH THE USE OF FROSTBITE (MATERIAL NUMBER 3803100; LOT NUMBER 061221). THEY REPORTED AN ALLERGIC REACTION WHEN SPRAYING THE FROSTBITE INTO A CRYOSTAT. DUE TO FROSTBITE BEING IN AN AEROSOL CAN, THE PRODUCT WAS PRESENT IN THE AIR WHEN THE PRODUCT WAS SPRAYED. THE PRODUCT WAS NOT SPRAYED INTO THE REPORTER'S EYES DIRECTLY. THE SYMPTOMS REPORTED INCLUDED WATERING AND SWELLING OF THE EYES, WHICH CAUSED THEM TO HAVE VISION TROUBLE. THE REPORTER SOUGHT MEDICAL ATTENTION FROM AN OPHTHALMOLOGIST. THE OPHTHALMOLOGIST PRESCRIBED STEROID DROPS AND AN ANTIHISTAMINE FOR TREATMENT. NO FURTHER MEDICAL ATTENTION WAS REQUIRED. THE REPORTER NOTED THAT THE SPRAY CAN WAS SPRAYED INSIDE OF A CRYOSTAT AND THE USER WAS NOT WEARING EYE PROTECTION AT THE TIME OF THE INCIDENT. THE PRODUCT LABEL WAS REVIEWED. THE LABEL DOES CONTAIN A WARNING FOR A HAZARDOUS MATERIAL AND TO CONSULT THE SAFETY DATA SHEET (SDS) FOR ADDITIONAL HAZARDS. A REVIEW OF THE SDS SHOWS THE PRODUCT REQUIRES GOOD VENTILATION OF THE WORK STATION AS WELL AS TO WEAR PERSONAL PROTECTIVE EQUIPMENT. DUE TO THE USE OF THE PRODUCT AS STATED, THE REPORTER WAS USING THE PRODUCT OFF-LABEL. A REVIEW OF THE DEVICE HISTORY FILE SHOWED THE PRODUCT PASSED ALL QUALITY INSPECTIONS PRIOR TO PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE REPORTER CALLED TO REPORT AN ADVERSE EVENT THAT THEY ASSOCIATED WITH THE USE OF FROSTBITE (MATERIAL NUMBER 380100; LOT NUMBER 061221). THEY REPORTED AN ALLERGIC REACTION WHEN SPRAYING THE FROSTBITE INTO A CRYOSTAT. DUE TO FROSTBITE BEING IN AN AEROSOL CAN, THE PRODUCT WAS PRESENT IN THE AIR WHEN THE PRODUCT WAS SPRAYED. THE PRODUCT WAS NOT SPRAYED INTO THE REPORTER'S EYES DIRECTLY. THE SYMPTOMS REPORTED INCLUDED WATERING AND SWELLING OF THE EYES, WHICH CAUSED THEM TO HAVE VISION TROUBLE. THE REPORTER SOUGHT MEDICAL ATTENTION FROM AN OPHTHALMOLOGIST. THE OPHTHALMOLOGIST PRESCRIBED STEROID DROPS AND AN ANTIHISTAMINE FOR TREATMENT. NO FURTHER MEDICAL ATTENTION WAS REQUIRED. THE REPORTER NOTED THAT THE SPRAY CAN WAS SPRAYED INSIDE OF A CRYOSTAT AND THE USER WAS NOT WEARING EYE PROTECTION AT THE TIME OF THE INCIDENT. THE PRODUCT LABEL WAS REVIEWED. THE LABEL DOES CONTAIN A WARNING FOR A HAZARDOUS MATERIAL AND TO CONSULT THE SAFETY DATA SHEET (SDS) FOR ADDITIONAL HAZARDS. A REVIEW OF THE SDS SHOWS THE PRODUCT REQUIRES GOOD VENTILATION OF THE WORK STATION AS WELL AS TO WEAR PERSONAL PROTECTIVE EQUIPMENT. DUE TO THE USE OF THE PRODUCT AS STATED, THE REPORTER WAS USING THE PRODUCT OFF-LABEL. A REVIEW OF THE DEVICE HISTORY FILE SHOWED THE PRODUCT PASSED ALL QUALITY INSPECTIONS PRIOR TO PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750584 FROSTBITE FROSTBITE, PRODUCT CODE: LEA LEA LEICA BIOSYSTEMS 3803100 061221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other