BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 10829218 · Received November 10, 2020

    Report

    Report Number
    MW5097792
    Event Type
    Injury
    Date Received
    November 10, 2020
    Report Date
    November 5, 2020
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) CNSS REPORTING PATIENT IS HAVING ISSUES WITH CLEO. PATIENT IS ONLY (B)(6) AND DOES NOT HAVE A LOT OF SUBCUTANEOUS TISSUE SO SITE KEEP FALLING OUT/ LEAKING. PATIENT WAS SWITCHED TO SILHOUETTE. NO OTHER INFORMATION AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279662 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1