BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INF SET CLEO 24" 9MM

    MDR report key: 16993923 · Received May 23, 2023

    Report

    Report Number
    MW5117787
    Event Type
    Injury
    Date Received
    May 23, 2023
    Report Date
    May 20, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER CNSS VISIT REPORT, PT HAS AT LEAST WEEKLY SUBCUTANEOUS SITE CHANGES DUE TO ITCHINESS AND CLEO SITE LOCALIZED SWELLING. PT CONTINUES TO HAVE SEVERAL CIRCUMFERENTIAL NON-PALPABLE PURPURA FROM PREVIOUS DEO SITES IN SEVERAL STAGES OF HEALING THROUGHOUT HIS ABDOMEN. PT REPORTS THAT HE CHANGED HIS LAST DEO SITE ON (B)(6) 2023 AND HE WOULD LIKE TO CONTINUE TO TRY TO USE THE CLEO INFUSION SETS FOR HIS ADMINISTRATION WHILE MONITORING FOR ANY CHANGES. PATIENT HAS CONCERNS THAT IT WAS JUST A "BAD BOX OF CLEO INJECTORS" THAT HAS LED HIM TO HAVE FREQUENT SITE CHANGES. UNKNOWN IF INFUSION SETS ARE AVAILABLE FOR RETURN/INVESTIGATION. NO OTHER INFORMATION, DATES, OR DETAILS PROVIDED. LOT NUMBER NOT PROVIDED/UNKNOWN. NO MISSED DOSES REPORTED. INDICATION: SECONDARY PULMONARY ARTERIAL HYPERTENSION. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650297 INF SET CLEO 24" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21723024

    Patients

    Seq Age Sex Outcome Treatment
    1 Male