BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AADCO

    MDR report key: 109434 · Received July 30, 1997

    Report

    Report Number
    MW1011785
    Event Type
    Malfunction
    Date Received
    July 30, 1997
    Date of Event
    June 16, 1997
    Report Date
    July 30, 1997
    Manufacturer
    AADCO MEDICAL ADVANCED PRODUCTS
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONTAMINATED APRON. CO IS AWARE OF PRODUCT PROBLEM AND WANTS THE PRODUCT BACK. FACILITY CAN NOT SEND A RADIOACTIVE COMPONENT BY LAW TO THE CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AADCO LEAD APRON EAJ AADCO MEDICAL ADVANCED PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN