BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINSMART IOD

    MDR report key: 3192329 · Received June 18, 2013

    Report

    Report Number
    1722139-2013-01969
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    January 1, 2009
    Report Date
    June 18, 2009
    Manufacturer
    MOOG DEVICE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PLATEN BENT CAUSED DOOR NOT TO CLOSE, REPLACE PLATEN ASSEMBLY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED STATES THAT PUMP'S DOOR PLATEN IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277280 PAINSMART IOD FRN MOOG DEVICE GROUP PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1