BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROPHYFLEX 3

    MDR report key: 558136 · Received November 23, 2004

    Report

    Report Number
    1419798-2004-00001
    Event Type
    Other
    Date Received
    November 23, 2004
    Date of Event
    November 8, 2004
    Report Date
    November 11, 2004
    Manufacturer
    KAVO AMERICA
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HYGIENIST FROM A DENTAL FACILITY REPORTED THAT A PT EXPERIENCED DISCOMFORT WHILE HAVING THEIR TEETH CLEANED WITH THE PROPHYFLEX 3. IT WAS REPORTED THAT THE PT PLACED THEIR HANDS ON THEIR THROAT AS IF THEY WERE CHOKING. 911 WAS CALLED AND THE PT WAS TRANSFERRED TO THE E.R. WHERE THEY WERE ADMINISTERED BENDADRYL (ROUTE AND DOSE UNKNOWN). IT WAS REPORTED WHILE AT THE E.R., THE PT WAS FOUND TO HAVE A POCKET OF AIR NEAR THEIR CERVICAL SPINE. HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED. THE PT HAS RECOVERED AND THE AIR POCKET IS REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPHYFLEX 3 HANDPIECE, AIR-POWERED, DENTAL EFB KAVO AMERICA PROPHYFLEX 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other