BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SAF PUMP

    MDR report key: 1943571 · Received December 6, 2010

    Report

    Report Number
    2026095-2010-00294
    Event Type
    Other
    Date Received
    December 6, 2010
    Report Date
    November 4, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    FAST FLOW. NO ADVERSE EVENT REPORTED. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SAF PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. CB004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK