BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1833867 · Received September 8, 2010

    Report

    Report Number
    2026095-2010-00159
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT PUMP SHOULD HAVE LASTED 48 HOURS, BUT WAS EMPTY IN 24 HOURS. PLACED ON (B)(6) 2010, AND WHEN HE WOKE ON (B)(6) 2010, HIS CLOTHING WAS WET AT THE INSERTION SITE. SEEMS ALL FLUID CAME BACK OUT THE INSERTION SITE, VERY WET THERE. NO OTHER LEAKAGE NOTED BY PATIENT. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER ELASTOMERIC INFUSION PUMP MEB I-FLOW CORPORATION P100X2 032638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK