BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYGENIC

    MDR report key: 7996461 · Received October 23, 2018

    Report

    Report Number
    2416455-2018-00013
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Report Date
    December 10, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EIE
    UDI-DI
    D661H091051
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT: (B)(4).

    Description of Event or Problem · 1

    DURING A ROOT CANAL, THE NON-LATEX DENTAL DAM SPLIT AND CAME OFF OVER CLAMP PATIENT WAS UNAWARE OF WHAT HAPPENED. THIS PRODUCT HAS BEEN USED MANY TIMES BEFORE WITHOUT AN ISSUE. ALL PARTS WERE RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837026 HYGENIC DENTAL DAM EIE COLTENE WHALEDENT INC. J072568 D661H091051

    Patients

    Seq Age Sex Outcome Treatment
    1