BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYGENIC

    MDR report key: 7808723 · Received August 23, 2018

    Report

    Report Number
    2416455-2018-08238
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    May 9, 2018
    Report Date
    September 21, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EEF
    UDI-DI
    D661H027060
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DENTAL CLAMP BROKE WHEN PLACING IN MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652290 HYGENIC DENTAL CLAMP EEF COLTENE WHALEDENT INC. D661H027060

    Patients

    Seq Age Sex Outcome Treatment
    1