BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KERR

    MDR report key: 565189 · Received December 25, 2004

    Report

    Report Number
    MW1034289
    Event Type
    Injury
    Date Received
    December 25, 2004
    Report Date
    December 25, 2004
    Manufacturer
    KERR CORP.
    Product Code
    EMN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE CO, KERR CORP, DIV OF SYBRON DENTAL SPECIALTIES PRODUCES CLASS II MEDICAL DEVICES AND DOES NOT CONDUCT ANY LIMULUS AMEBOCYTE LYSATE TESTS ON ANY OF ITS PRODUCTS AS REQUIRED BY THE FDA GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERR DENTAL MATERIALS EMN KERR CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention