BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRADITION

    MDR report key: 115460 · Received August 21, 1997

    Report

    Report Number
    1419322-1997-90001
    Event Type
    Malfunction
    Date Received
    August 21, 1997
    Date of Event
    July 15, 1997
    Report Date
    August 5, 1997
    Manufacturer
    MIDWEST DENTAL PRODUCTS
    Product Code
    EFB
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CAP ON THE BACK OF THE HANDPIECE CAME OFF IN THE PT'S MOUTH AND WAS SWALLOWED. X-RAY CONFIRMED IT WAS SWALLOWED AND 10 DAYS LATER X-RAY CONFIRMED IT WAS PASSED OUT OF THE BODY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other