BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 15632522 · Received October 18, 2022

    Report

    Report Number
    MW5112719
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Report Date
    September 2, 2022
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS CALL PT SAID HER LAST BATCH OF DEO SET WAS NOT ADHERING PROPERLY TO HER SKIN. ASKED THE PT IF THIS HAPPENED BEFORE AND SHE SAID NO IT ONLY HAPPENED WITH THE LAST BATCH. TOLD HER WE WILL SEND HER A NEW BATCH AND IF THAT STILL IS HAPPENING TO CALL US TO TROUBLESHOOT. NO LOT TRACKED IN DISPENSING SYSTEM. UNKNOWN IF PATIENT MISSED A DOSE OR IF SHE HAD AN ADVERSE EVENT. UNKNOWN IF PRODUCT ON HAND FOR RETURN. NO OTHER INFORMATION KNOWN AVAILABLE. CONSENT QUESTIONS WAS NOT ASKED. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819775 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 21723124

    Patients

    Seq Age Sex Outcome Treatment
    1 Female