BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD APRON

    MDR report key: 119425 · Received July 18, 1997

    Report

    Report Number
    MW1012067
    Event Type
    Malfunction
    Date Received
    July 18, 1997
    Date of Event
    May 8, 1997
    Report Date
    July 17, 1997
    Manufacturer
    BURLINGTON MEDICAL SUPPLIES, INC.
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    RADIOLOGY SVC REPORTS THESE CONTAMINATED LEAD SHIELDING PRODUCTS: APRON, WRAP-AROUND READING 0/13 MR, THYROID SHIELD READING 0.13 MR, APRON, WRAP-AROUND READING 0.14 MR, THYROID SHIELD READING 0.12 MR, APRON, VEST ONLY READING 0.14 MR, AND THYROID SHIELD READING 0.14 MR. THESE ITEMS WERE SENT BACK TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD APRON LEAD APRON EAJ BURLINGTON MEDICAL SUPPLIES, INC. * *
    2 THYROID SHEILD THYROID SHIELD KPY BURLINGTON MEDICAL SUPPLIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *