BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYGENIC

    MDR report key: 7808692 · Received August 23, 2018

    Report

    Report Number
    2416455-2018-08237
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    June 4, 2018
    Report Date
    September 21, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EIE
    UDI-DI
    D661H116270
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DENTAL DAM TORE IN PATIENTS MOUTH AFTER GETTING WET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652498 HYGENIC DENTAL DAM EIE COLTENE WHALEDENT INC. 160J7 D661H116270

    Patients

    Seq Age Sex Outcome Treatment
    1