BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 111100 · Received August 6, 1997

    Report

    Report Number
    MW1011830
    Event Type
    Malfunction
    Date Received
    August 6, 1997
    Report Date
    August 6, 1997
    Manufacturer
    BAR-RAY PRODUCTS, INC.
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN JANUARY 1997 FACILITY PURCHASED 3 APRONS, MFG BY BAR-RAY AND PURCHASED FROM A DISTRIBUTOR. THESE APRONS HAVE BEEN SURVEYED BY THE HOSP PHYSICIST AND DO REVEAL CONTAMINATION. DISTRIBUTOR HAS BEEN NOTIFIED AND FACILITY IS WAITING ON INSTRUCTIONS FROM THE MFR. THESE APRONS ARE NOT IN USE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LEAD APRON EAJ BAR-RAY PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *