BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART IOD

    MDR report key: 3237402 · Received July 9, 2013

    Report

    Report Number
    1722139-2013-02434
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    January 1, 2009
    Report Date
    June 25, 2009
    Manufacturer
    MOOG MEDICAL DEVICE GRP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALIBRATED THE VOLUMETRIC AND RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    INFO RECEIVED STATES THAT VOLUMETRIC INFUSION WAS HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314308 PAINSMART IOD FRN MOOG MEDICAL DEVICE GRP PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1