BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-RAY FILM MARKING TAPE

    MDR report key: 98688 · Received June 17, 1997

    Report

    Report Number
    MW4001921
    Event Type
    Malfunction
    Date Received
    June 17, 1997
    Report Date
    September 30, 1996
    Manufacturer
    SPECTRONICS, CORP.
    Product Code
    JAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AP, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LABELS ARE USED TO MARK INDUSTRIAL RADIOGRAPHIC FILM USED WHEN PERFORMING X-RAY INSPECTIONS ON AIRCRAFT. THE LABELS MUST HAVE ALL IDENTIFYING INFO EMBOSSED, NORMALLY WITH A BALL-POINT PEN, IN THE GREY PUTTY CENTER OF THE TAPE. UPON EXPOSURE TO X-RAYS, THIN AREAS WHERE WRITING HAS BEEN MADE LEAVE AN IMAGE OF ALL IDENTIFYING INFO ON THE XRAY FILM. IN THIS CASE, THE PUTTY IN THE LABEL HAS BECOME SO DECOMPOSED THAT IT HAS TURNED FROM A GRAY PUTTY TO AN OFF-WHITE POWDER. RPTR'S EXPERIENCE IS THAT THIS CONDITION NORMALLY OCCURS DUE TO EITHER TIME SINCE MFR OR IMPROPER STORAGE AND RENDERS THE LABEL UNSERVICEABLE. VERY OLD PRODUCT. MFR DATE 6/82, 12/82.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-RAY FILM MARKING TAPE X-RAY FILM MARKING TAPE JAC SPECTRONICS, CORP. 314X - 175 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *