BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFUSER PAIN CONTROL PUMP

    MDR report key: 2250964 · Received August 31, 2011

    Report

    Report Number
    1722139-2011-00288
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    MEB
    PMA / PMN Number
    K050770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE PUMP LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFUSER PAIN CONTROL PUMP MEB MOOG MEDICAL DEVICES GROUP T4060LYK5-CP CP 17916

    Patients

    Seq Age Sex Outcome Treatment
    1