BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTIMA LEAD APRON

    MDR report key: 139883 · Received December 15, 1997

    Report

    Report Number
    2411512-1997-00010
    Event Type
    Other
    Date Received
    December 15, 1997
    Date of Event
    October 20, 1997
    Report Date
    October 20, 1997
    Manufacturer
    E-Z-EM, INC.
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    E-Z-EM, INC WAS UNABLE TO DETERMINE THE EXACT DATE OF MANUFACTURE FOR THE APRON DUE TO THE INABILITY TO OBTAIN THE DISTRIBUTOR PURCHASE ORDER NUMBER. HOWEVER, THE LOT REPRESENTS PRODUCT MANUFACTURED SUBSEQUENT TO JUNE 1997.

    Description of Event or Problem · 1

    CUSTOMER REC'D REPLACEMENT PRODUCT FROM THE APRON RECALL AND CLAIMED THAT THE REPLACEMENT HAD A HOLE IN THE LEAD. E-Z-EM IS FILING THIS EVENT DUE TO THE POTENTIAL FOR HARM HAD THIS NOT BEEN CAUGHT BY THE X-RAY TECHNOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA LEAD APRON LEAD PROTECTIVE GARMENT EAJ E-Z-EM, INC. NA 97206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other