BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURKHART ROENTGEN RADIATION SHIELD

    MDR report key: 295318 · Received September 1, 2000

    Report

    Report Number
    MW4002840
    Event Type
    Injury
    Date Received
    September 1, 2000
    Date of Event
    August 14, 2000
    Report Date
    September 1, 2000
    Manufacturer
    BURKHART ROENTGEN INT'L, INC.
    Product Code
    IWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING A PROCEDURE, THE RADIATION SHIELD DETACHED FROM ITS SUSPENSION ARM AND FELL, STRIKING THE PT'S ARM AND THE RADIOLOGIST'S WRIST. THE RADIOLOGIST SUSTAINED A HAIRLINE FRACTURE OF HIS WRIST. THE EXTEND OF INJURY, IF ANY, TO THE PT IS UNK AT THIS TIME. REPORTEDLY, THE RADIATIONSHIELD FELL DUE TO A BROKEN WELD ON THE YOKE WHICH HOLDS THE SHIELD ON THE SUSPENSION ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURKHART ROENTGEN RADIATION SHIELD PERSONNEL PROTECTIVE SHIELD IWQ BURKHART ROENTGEN INT'L, INC. BK2001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention