BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K09-10198 CONVENIENCE KIT

    MDR report key: 1374908 · Received April 30, 2009

    Report

    Report Number
    1721504-2009-00064
    Event Type
    Injury
    Date Received
    April 30, 2009
    Date of Event
    March 24, 2009
    Report Date
    March 31, 2009
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE DID NOT MALFUNCTION; THEREFORE, AN EVAL WILL NOT BE PERFORMED. THE HOSPITAL INITIALLY NOTIFIED ALL MANUFACTURERS OF DEVICES THAT HAD ANY CONTACT WITH THE PT OF THE ALLERGIC REACTION. A SUBSEQUENT REPORT FROM THE HOSPITAL REVEALED NEW INFORMATION REGARDING THE PT. SPECIFICALLY, THE PT HAD SHELLFISH AND DYE ALLERGIES. THE HOSPITAL DID NOT ATTRIBUTE THE ADVERSE EVENT TO CONTACT WITH THE SUSPECT DEVICE. THE MANUFACTURER DOES NOT EXPECT TO RECEIVE ANY ADDITIONAL INFORMATION REGARDING THIS COMPLAINT; HOWEVER, IF NEW INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED A PT EXPERIENCED AN ALLERGIC REACTION AFTER A PROCEDURE WAS PERFORMED WITH THE SUSPECT DEVICE. THE PT WAS TREATED WITH BENADRYL AND STEROIDS. THE HOSPITAL DID NOT ATTRIBUTE THE ADVERSE EVENT TO CONTACT WITH THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K09-10198 CONVENIENCE KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. NA F693476

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R