BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIESTA

    MDR report key: 7800595 · Received August 21, 2018

    Report

    Report Number
    2416455-2018-00011
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    May 1, 2018
    Report Date
    August 28, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EEF
    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

    THE DENTAL CLAMP BROKE DURING USE WHILE THE DENTIST USED THE CLAMP IN THE MANDIBULAR LOWER JAW STARTING FROM NUMBER 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641281 FIESTA DENTAL CLAMP EEF COLTENE WHALEDENT INC. H09964

    Patients

    Seq Age Sex Outcome Treatment
    1