BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICE COOLING SPRAY

    MDR report key: 20453107 · Received October 11, 2024

    Report

    Report Number
    MW5161044
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 9, 2024
    Manufacturer
    UNK
    Product Code
    EAT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING A DEVICE USED DURING A DENTAL PROCEDURE CALLED ICE COOLING SPRAY. PATIENT STATED THE DEVICE WAS APPLIED ON (B)(6) 2024 AT THE DENTAL OFFICE FOR TOOTH TESTING AND SHE EXPERIENCED A TERRIBLE REACTION INCLUDING VOMITING FOR 3 HOURS AND DEHYDRATION. PATIENT STATED SHE BELIEVES THE DEVICE WAS MISUSED AS THE PROVIDER DIDN'T FOLLOW INSTRUCTIONS AND RINSE AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345371 ICE COOLING SPRAY TESTER, PULP EAT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other