BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIET AIR

    MDR report key: 385249 · Received March 28, 2002

    Report

    Report Number
    1419322-2002-00008
    Event Type
    Injury
    Date Received
    March 28, 2002
    Report Date
    March 25, 2002
    Manufacturer
    MIDWEST DENTAL PRODUCTS
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DENTIST ALLEGES THAT THEY WERE DIAGNOSED WITH TINITTUS, RINGING OF THE EARS, ABOUT THREE YEARS AGO. FAMILY MEMBER, A RECEPTIONIST IN PATIENT'S OFFICE, WAS ALSO RECENTLY DIAGNOSED WITH TINITTUS. THE DOCTOR WHO DIAGNOSED THIS ALLEGED IT WAS DUE TO THE HANDPIECES THAT THE DOCTOR USES IN THEIR PRACTICE. FAMILY MEMBER IS IN THE FRONT OFFICE AND DOES NOT WORK WITH OR AROUND THE HANDPIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIET AIR DENTAL HANDPIECE EFB MIDWEST DENTAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability