BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINKHORST TIP

    MDR report key: 14342 · Received June 24, 1994

    Report

    Report Number
    MW1002597
    Event Type
    Malfunction
    Date Received
    June 24, 1994
    Date of Event
    June 21, 1994
    Report Date
    June 21, 1994
    Manufacturer
    RHEIN MEDICAL
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR STATES RUST-LIKE PARTICLES BLOW OUT OF IRRIGATION PORTS. HE STATES THIS HAS HAPPENED A NUMBER OF TIMES WITH THIS TIP STYLE, AND THAT THE TIPS WERE RETURNED TO THE MFR EACH TIME. HE STATES THE MFR CLAIMED THEY COULD FIND NO PROBLEM AND SENT HIM A NEW TIP. THE FIRST TIP OF THIS STYLE USED HAD VISABLE RUST ON THE SURFACE. HE HAS USED OTHER TIPS WITH THE SAME UNIVERAL HANDPIECE AND HAS HAD NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BINKHORST TIP UNIVERSAL HANDPIECE HQE RHEIN MEDICAL 99 IN 90306

    Patients

    Seq Age Sex Outcome Treatment
    1 *