BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART IOD PUMP

    MDR report key: 4161794 · Received July 24, 2014

    Report

    Report Number
    1722139-2014-00126
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MOOG MEDICAL DEVICE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED PM AND CORRECTED DAMAGE TO REAR OF DEVICE. PUMP PERFORMS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    INFO INDICATES PUMP WAS UNDER-INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433104 PAINSMART IOD PUMP PAIN MANAGEMENT PUMP FRN MOOG MEDICAL DEVICE GROUP IOD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR