BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH ONDEMAND

    MDR report key: 7221363 · Received January 25, 2018

    Report

    Report Number
    MW5074874
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    January 23, 2018
    Report Date
    January 24, 2018
    Manufacturer
    HALYARD
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE ON-Q PAIN RELIEF SYSTEM WITH ON DEMAND PRODUCED BY HALYARD HAS A MALFUNCTIONING CAP. AT THE END OF THE LINING, THE CAP IS NOT STAYING SECURE RESULTING IN THE ON-Q DEVICE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64373 ON-Q PAIN RELIEF SYSTEM WITH ONDEMAND ON-Q PAIN RELIEF SYSTEM MEB HALYARD 0202807691

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention