BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY RUBBER DAM CLAMP 4

    MDR report key: 83862 · Received April 10, 1997

    Report

    Report Number
    1925223-1997-00153
    Event Type
    Malfunction
    Date Received
    April 10, 1997
    Report Date
    March 25, 1997
    Manufacturer
    HERAEUS KULZER, INC.
    Product Code
    EEF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    CLAMP BROKE ON FIRST USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY RUBBER DAM CLAMP 4 RUBBER DAM CLAMP EEF HERAEUS KULZER, INC. * P6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN