BEUDAMED
    FDA Adverse Event Summary report: N

    IVORY RUBBER DAM CLAMP #13A

    MDR report key: 65311 · Received January 24, 1997

    Report

    Report Number
    1925223-1997-00001
    Date Received
    January 24, 1997
    Date of Event
    December 17, 1996
    Report Date
    January 14, 1997
    Manufacturer
    HERAEUS KULZER, INC. DENTAL PRODUCTS DIV.
    Product Code
    EEF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    DENTIST WAS DOING A ROOT CANAL WHEN THE CLAMP BROKE. RUBBER DAM TECHNIQUE WAS BEING USED. ENDO FILES IN MOUTH AND CLAMP POPPED OFF. FEELS CLAMPS ARE DEFECTIVE OR TOO SMALL. THE DENTIST FELT THE CLAMPS ARE REALLY TIGHT; COMING BACK TIGHT IN THE MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY RUBBER DAM CLAMP #13A RUBBER DAM CLAMP EEF HERAEUS KULZER, INC. DENTAL PRODUCTS DIV. NA A6

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other