BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXPLORER SE #23

    MDR report key: 511767 · Received February 17, 2004

    Report

    Report Number
    2411236-2004-10831
    Event Type
    Other
    Date Received
    February 17, 2004
    Date of Event
    December 1, 2003
    Report Date
    February 17, 2004
    Manufacturer
    SHANGHAI DENTAL INSTRUMENT FACTORY
    Product Code
    EKB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    NOTIFICATION RECEIVED OF AN EXPLORER TIP BREAKING OFF IN A PT'S MOUTH. THE PT SUBSEQUENTLY SWALLOWED THE TIP. PT HAD X-RAYS TAKEN AND TO THE REPORTER'S KNOWLEDGE IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPLORER SE #23 DENTAL INSTRUMENT EKB SHANGHAI DENTAL INSTRUMENT FACTORY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other