BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONEX ORTHO L

    MDR report key: 159612 · Received March 24, 1998

    Report

    Report Number
    1043882-1998-00001
    Event Type
    Malfunction
    Date Received
    March 24, 1998
    Date of Event
    February 24, 1998
    Report Date
    March 20, 1998
    Manufacturer
    STERLING DIAGNOSTIC IMAGING
    Product Code
    IWZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADIOLOGY ADMINISTRATOR HAS NOT RESPONDED TO CO'S WRITTEN REQUEST FOR THE REQUIRED PRODUCT INFO TO PERFORM AN INVESTIGATION. THE RADIOLOGY ADMINISTRATOR COMMUNICATED VERBALLY TO CO'S SALES MANAGEMENT THAT HE REVIEWED CO'S WRITTEN REQUEST WITH THE RADIOLOGIST INVOLVED WITH THE EVENT AND CHAIRMAN OF THE RADIOLOGY DEPT. THEY ELECTED NOT TO REPLY TO CO'S REQUEST AND CONSIDER THE ISSUE CLOSED. CO HAS CONTINUED TO MONITOR COMPLAINT RECORDS WITH NO INDICATION OF A TREND RELATIVE TO THIS ALLEGED EVENT. PLEASE CONSIDER THIS CO'S FINAL REPORT.

    Description of Event or Problem · 1

    A RADIOLOGIST COMMENTED TO A STERLING DI ACCOUNT EXECUTIVE ALLEGING THAT THE STERLING RADIOGRAPHIC FILM USED IN THE RADIOGRAPHIC STUDY OF A HIP HAD FAILED TO IMAGE A FRACTURE. THE PT REC'D A FOLLOW-UP X-RAY AT ANOTHER LOCATION WHERE UPON THE FRACTURE WAS DETECTED. NO SERIOUS INJURY OR ADVERSE HEALTH CONSEQUENCE WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONEX ORTHO L RADIOGRAPHIC FILM IWZ STERLING DIAGNOSTIC IMAGING * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other