BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIDWEST QUIET AIR STANDARD 4 HOLE HANDPIECE

    MDR report key: 128257 · Received October 23, 1997

    Report

    Report Number
    1419322-1997-00008
    Event Type
    Other
    Date Received
    October 23, 1997
    Date of Event
    December 7, 1995
    Report Date
    October 22, 1997
    Manufacturer
    MIDWEST DENTAL
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY SUSTAINED ACUTE-ONSET SUBCUTANEOUS EMPHYSEMA DURING A DENTAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDWEST QUIET AIR STANDARD 4 HOLE HANDPIECE DENTAL HANDPIECE EFB MIDWEST DENTAL QUIET AIR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other