BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1032952 · Received April 23, 2008

    Report

    Report Number
    2026095-2008-00036
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    January 29, 2008
    Report Date
    March 24, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INITIAL REPORTER INDICATED THAT NO SAMPLE WAS AVAILABLE FOR EVAL AND INVESTIGATION. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. A FEMALE HAD SHOULDER SURGERY IN 2007, WAS DIAGNOSED WITH CHONDROLYSIS IN 2008. NO PROBLEMS WITH THE OPERATION OF THE PUMP WERE REPORTED. IT WAS REPORTED THAT THE CATHETER WAS PLACED EXTRA-ARTICULARLY. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    A PT DEVELOPED CHONDROLYSIS APPROX 8 MONTHS POST SHOULDER SURGERY. IT WAS REPORTED THAT THE ON-Q PUMP WAS USED AND THE CATHETER WAS PLACED EXTRA-ARTICULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM014 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other