BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC ENDO-ICE REFRIGERANT SPRAY

    MDR report key: 12134552 · Received July 8, 2021

    Report

    Report Number
    2416455-2021-00002
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 15, 2021
    Product Code
    EAT
    UDI-DI
    D661H050320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - CLINICAL CODE 4581 WAS USED FOR THIS ADVERSE EVENT. THE CUSTOMER WAS EXPERIENCING EXCESS MUCOUS. THE CAN OF ENDO-ICE ASSOCIATED WITH THIS ADVERSE EVENT WAS NOT AVAILABLE FROM THE CUSTOMER BECAUSE THE DENTAL OFFICE CONTINUED TO USE THE PRODUCT UNTIL EMPTY AND THREW AWAY THE CAN. AS OF 08/26/2021, NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PRODUCT FROM THIS DENTAL OFFICE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THE DENTIST'S OFFICE WAS CONTACTED ON (B)(6) 2021 REGARDING THE COMPLAINT. THE DENTIST OFFICE CONFIRMED THAT ENDO-ICE WAS USED AND THAT IT WAS SPRAYED ON A PELLET IN THE BACK OF THE ROOM AWAY FROM THE PATIENT. ACCORDING TO THE DENTIST NOTES, THE PATIENT CAME IN FOR EVALUATION OF HER LOWER RIGHT AREA. ENDO-ICE WAS SPRAYED ON A COTTON PELLET AT THE BACK OF THE ROOM AND THEN PLACED ON THE TOOTH. THE PATIENT SEEMED TO HAVE A REACTION TO THE ENDO-ICE AND STATED THAT THE FUMES/TASTE BURNED HER THROAT. NO FURTHER COLD TREATMENT WAS PERFORMED BY THE DENTIST. THE DENTIST DID PROVIDE WATER AND MOUTHWASH TO THE PATIENT. THE DENTAL OFFICE INDICATED THAT THE PATIENT DID NOT MENTION ANYTHING ABOUT DRIPS OF ENDO-ICE IN HER THROAT AND THAT ONLY FUMES/TASTES WERE MENTIONED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE VISITED THE DENTIST'S OFFICE ON (B)(6) 2021. WHEN DOCTOR WAS DOING PROCEDURE, THE INSTRUMENT THAT HE WAS USING HAD ENDO-ICE ON IT. (THE PATIENT DID NOT SEE THE INSTRUMENT BEING SPRAYED; HOWEVER, THIS IS WHAT WAS TOLD TO HER). WHEN THE INSTRUMENT WAS PLACED ON HER TOOTH, SOME OF THE SPRAY DRIPPED DOWN HER THROAT. SHE DID SWALLOW IT. SHE STATED THAT IT HAD A HORRIBLE TASTE AND HER SALIVA WAS FOAMY WHEN SHE SPIT IT OUT INTO A CUP. THE OFFICE DID GIVE HER WATER TO DRINK AFTERWARDS. THE PATIENT NOW HAS A LOT OF MUCUS AND A VERY SORE THROAT, CHEST PAINS, HER TONGUE IS SORE, SHORTNESS OF BREATH, FATIGUE, AND A COUGH. SHE SAID THAT SHE HAD NONE OF THESE SYMPTOMS BEFORE THIS INCIDENT. SHE WAS ADVISED TO GO TO HER DOCTOR FOR EVALUATION BY DENTIST OFFICE. THE PATIENT WAS CONTACTED DIRECTLY ON (B)(6) 2021. SHE INDICATED THAT SHE SWALLOWED 3 DROPS OF ENDO- ICE THAT DRIPPED INTO HER THROAT FROM THE COTTON BALL. THREE DAYS AFTER THE INCIDENT SHE WENT TO THE EMERGENCY ROOM FOR EVALUATION. THE EMERGENCY ROOM DOCTOR ADVISED THAT SHE CONTACT A GI DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033171 HYGENIC ENDO-ICE REFRIGERANT SPRAY PULP TESTER EAT H05032 D661H050320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other