BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 106055 · Received July 1, 1997

    Report

    Report Number
    106055
    Event Type
    Malfunction
    Date Received
    July 1, 1997
    Date of Event
    June 27, 1997
    Report Date
    July 1, 1997
    Manufacturer
    AADCO MEDICAL INC.
    Product Code
    IWO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE IN THE CARDIAC CATHETERIZATION LABORATORY WAS EXPOSED TO RADIATION FROM THE LEAD IN THE PROTECTIVE LEAD APRON. THE APRONS WERE WORN APPROX 30 HOURS. THE RADIATION PHYSICIST STATED THE RADIATION EXPOSURE WAS LOW ENERGY BETA ADMITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE WRAP AROUND LEAD VEST & KILT IWO AADCO MEDICAL INC. LPA 681 VEST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other APRON WITH THYROID SHIELD LP800.