BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD, INC.

    MDR report key: 13368 · Received May 20, 1994

    Report

    Report Number
    13368
    Event Type
    Injury
    Date Received
    May 20, 1994
    Date of Event
    March 11, 1994
    Report Date
    March 23, 1994
    Manufacturer
    MEDRAD, INC.
    Product Code
    DQF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING AN IV CAROTID DSA WHEN SHE COMPLAINED OF ELECTRIC SHOCK. INVESTIGATION FOUND UNIT MET ALL SAFETY PARAMETERS ION STATIC MODE. WE COULD NOT DUPLICATE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD, INC. INJECTOR DQF MEDRAD, INC. H5P

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening