BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 10762623 · Received October 29, 2020

    Report

    Report Number
    MW5097565
    Event Type
    Injury
    Date Received
    October 29, 2020
    Report Date
    October 26, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER REPORTS SHE HAD TO CHANGE THE LAST SITE DUE TO A POSSIBLE INFECTION. SHE NOTED PUS COMING OUT AND REDNESS. PT HAD NO FEVER. MOM DID NOT CONTACT MD OFFICE, BUT PHARMACY HAS NOTIFIED MD. SHE HAS BEEN USING NEOSPORIN AND IT APPEARS TO BE GETTING BETTER. REMS ID: (B)(4). PRESCRIBER REMS ID: (B)(4). REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219260 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1