BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER SOAKER 5" EXPANSION KIT

    MDR report key: 2181131 · Received July 22, 2011

    Report

    Report Number
    2026095-2011-00196
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K043456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN REC'D, BUT WAS REPORTED TO BE AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. RESULTS: W/O THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN REC'D AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY (TAH/BSO). CATHPLACE: UNK. SHEATH FROM TUNNELER BROKE OFF INSIDE THE PT. SURGEON X-RAYED THE PT, FOUND THE SHEATH FRAGMENT APPROX 1 INCHES AND REMOVED THE SHEATH WHILE THE PT WAS STILL UNDER ANESTHESIA. PT SUFFERED NO DISCOMFORT. DATE OF SURGERY (B)(6). DATE OF EVENT: (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER 5" EXPANSION KIT PUMP, CATHETER, & SHEATH BSO I-FLOW CORPORATION PM020 142646

    Patients

    Seq Age Sex Outcome Treatment
    1 Other