BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUMBO CLEAR PB MOBILE X-RAY BARRIER

    MDR report key: 30874 · Received February 2, 1996

    Report

    Report Number
    30874
    Event Type
    Malfunction
    Date Received
    February 2, 1996
    Date of Event
    May 1, 1995
    Report Date
    August 16, 1995
    Manufacturer
    RADMART CORPORATION
    Product Code
    IWX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCREEN RECEIVED 6/94. NOTIFIED ON 5/1/95 OF PRODUCT RECALL BECAUSE SCREEN DID NOT CONTAIN LEAD. SCREEN REMOVED FROM SERVICE. EQUIPMENT INCIDENT REPORTED TO PT RELATIONS DEPARTMENT ON 7/25/95. PT RELATIONS DEPARTMENT FOLLOWED-UP WITH DISTRIBUTOR WHO HAS MADE A MED WATCH REPORT. PHYSICIAN AND EMPLOYEES USED SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUMBO CLEAR PB MOBILE X-RAY BARRIER JUMBO CLEAR PB MOBILE X-RAY BARRIER IWX RADMART CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other