BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1971949 · Received January 24, 2011

    Report

    Report Number
    2026095-2011-00011
    Event Type
    Other
    Date Received
    January 24, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PUMP INFUSED TOO FAST. EMPTIED IN APPROXIMATELY 28 HOURS INSTEAD OF 67.5 HOURS. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER ELASTOMERIC PUMP MEB I-FLOW CORP. PM015-A 9B2252

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR